1. FDA Changes Process for Medical Device Advisory Committees
April 26, 2010 the FDA announced that it will change the way its expert panels review and discuss data and information during public hearings on medical devices under review for premarket approval. the panel will vote on the safety and effectiveness of a device and the device’s risk versus its benefit. Also the panels will vote using ballot instead of by a show of hands. These changes are going to be effective May 1, 2010.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm209791.htm
2. FDA recently announced a Medical Device Use in the Home Environment Workshop: Implications for the Safe and Effective Use of Medical Device Technology Migrating into the Home. The main purpose of the workshop to gather information from health care providers, academia, human factors experts, industry, medical device distributors, manufacturers, professional societies, patient advocate groups and patients on the issues and challenges with using medical device technology at home. The workshop will be held on May 24, 2010 at the Hilton in Silver Spring, MD.
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm205804.htm
3. May 3, 2010 the Board of Directors of the Biotechnology Industry Organization (BIO) elected a new group of officers and nine new board members at BIO’s 2010 International Convention.
http://www.bio.org/news/pressreleases/newsitem.asp?id=2010_0503_02
Monday, May 3, 2010
Friday, April 23, 2010
The Menaflex Episode—Who’s Really at Fault?
I guess by now anyone who works even peripherally with the medical device industry has heard about Menaflex and the “aggressive” tactics of its developers, ReGen Biologics Inc., in getting the product approved by FDA under the 510(k) pathway. Over the past year, numerous articles have been written on this case and pretty much every article has established how one company, when irritated by FDA reviewers involved with their product, went around the reviewers to their bosses up to FDA Commissioner, and used all resources at their disposal, including political connections, to get their product approved. FDA scientists got so miffed by this that they wrote to the US Congress, which in turn, led to a series of inquiries of FDA and all the surrounding hoopla.
While everyone is quick to rule against the company involved, let me try to put the shoe in the other foot. Menaflex had been approved and sold in Europe for several years and by the time, it got approved by FDA for use in the U.S., it had been implanted in more than 2600 patients with acceptable levels of safety episodes and re-surgeries. The company had been working on this device for at least 16 years; their first pre-IDE meeting with FDA was in 1992.
ReGen initially followed the PMA route and initiated a clinical trial in mid-Nineties and filed the first module of their PMA in 2004. However, there were some issues during the clinical trial, mostly procedural, and which seem to have resulted because of inadequate advice from their regulatory team about Good Clinical Practices (GCP). This led to a warning letter for the clinical trial. The company apparently addressed these issues and completed the trial according to publicity available information.
However, in 2005, about a year and half after their PMA filing, they decided to follow the 510(k) route. Their 510(k) applications got rejected twice, and seemingly with time, the degree of negative feelings between the company and the review team got stronger leading to the company filing complaints under the FDA ombudsman process and finally asked their local political leaders for help. The rest is history.
Say what you may, but even FDA’s internal inquiry found that the company had broken no rules. Some of the processes were stretched at the request of the company but at no time were reviewers asked to change their scientific opinion or do anything they were not comfortable with. However, the company did succeed in keeping the negative reviewers out of their advisory committee meeting and get their opinion overruled by their superiors.
You might not like the so-called “aggressive” attitude of the company but for a moment, put yourselves in their position: what would you do if you feel that the reviewers are being unreasonable with your product and trying to impose a higher-than-normal standard? Won’t you try everything in your power and rights to pursue the case where you can?
FDA has been doing many things due to the Menaflex episode. First, it held a public meeting to review if 510(k) process should be changed (read 510(k): Big Changes Ahead...). Then it reconvened the Advisory Committee on March 23, 2010 to re-review the data for Menaflex. This Committee concluded that the device has no safety issue although the efficacy seemed debatable. They did not conclude that the device posed unreasonable risk to the patients or that it is not at all efficacious. FDA announced that it is reconsidering if the device should be taken off the market. And we all wait with our fingers crossed.
So far the indications are there a little risk of the device being taken off the market. In their media brief following the release of the report of its internal review, FDA insisted that the device was approved legally. The Advisory Committee has concluded that the device does not pose a safety risk, and there are no alternate therapies available for the indication. So, if FDA decides to take this product off the market, it would be creating a dangerous precedence. Any product approval can be challenged for any reason. This time, it was the FDA scientists who went outside their agency to the Congress to raise voice about it; tomorrow it could be an outside party going to the Congress and challenging the FDA scientists.
More importantly, under current laws, FDA can take approved products off the market only if there is a safety risk. So, most likely FDA will not do this. However, they could come back and limit the market under one pretext or another. Even that seems hard without a clear evidence to support it. If this were to happen, it is not just ReGen that would suffer, but the entire medical device industry, as it would prove once for all that getting FDA approval is not the end of the road to market.
While I am not sure if this is the first time, I am still hopeful. I am not sure if we would have ever heard about this case if the FDA Commissioner who oversaw this process had still been at the head of the Agency. The approval was done on December 20, 2008, right after the Presidential elections. The FDA commissioner resigned on January 20, 2009, and the FDA scientists wrote to the Congress in late January against their boss. This issue does not leave anyone untouched – the company, FDA scientists, politicians who used their influence, even FDA lawyers who did not advise in time, per their own internal review. This episode is certainly a case-study we will all review for a long time about the dos and don’ts of interacting with the US FDA.
While everyone is quick to rule against the company involved, let me try to put the shoe in the other foot. Menaflex had been approved and sold in Europe for several years and by the time, it got approved by FDA for use in the U.S., it had been implanted in more than 2600 patients with acceptable levels of safety episodes and re-surgeries. The company had been working on this device for at least 16 years; their first pre-IDE meeting with FDA was in 1992.
ReGen initially followed the PMA route and initiated a clinical trial in mid-Nineties and filed the first module of their PMA in 2004. However, there were some issues during the clinical trial, mostly procedural, and which seem to have resulted because of inadequate advice from their regulatory team about Good Clinical Practices (GCP). This led to a warning letter for the clinical trial. The company apparently addressed these issues and completed the trial according to publicity available information.
However, in 2005, about a year and half after their PMA filing, they decided to follow the 510(k) route. Their 510(k) applications got rejected twice, and seemingly with time, the degree of negative feelings between the company and the review team got stronger leading to the company filing complaints under the FDA ombudsman process and finally asked their local political leaders for help. The rest is history.
Say what you may, but even FDA’s internal inquiry found that the company had broken no rules. Some of the processes were stretched at the request of the company but at no time were reviewers asked to change their scientific opinion or do anything they were not comfortable with. However, the company did succeed in keeping the negative reviewers out of their advisory committee meeting and get their opinion overruled by their superiors.
You might not like the so-called “aggressive” attitude of the company but for a moment, put yourselves in their position: what would you do if you feel that the reviewers are being unreasonable with your product and trying to impose a higher-than-normal standard? Won’t you try everything in your power and rights to pursue the case where you can?
FDA has been doing many things due to the Menaflex episode. First, it held a public meeting to review if 510(k) process should be changed (read 510(k): Big Changes Ahead...). Then it reconvened the Advisory Committee on March 23, 2010 to re-review the data for Menaflex. This Committee concluded that the device has no safety issue although the efficacy seemed debatable. They did not conclude that the device posed unreasonable risk to the patients or that it is not at all efficacious. FDA announced that it is reconsidering if the device should be taken off the market. And we all wait with our fingers crossed.
So far the indications are there a little risk of the device being taken off the market. In their media brief following the release of the report of its internal review, FDA insisted that the device was approved legally. The Advisory Committee has concluded that the device does not pose a safety risk, and there are no alternate therapies available for the indication. So, if FDA decides to take this product off the market, it would be creating a dangerous precedence. Any product approval can be challenged for any reason. This time, it was the FDA scientists who went outside their agency to the Congress to raise voice about it; tomorrow it could be an outside party going to the Congress and challenging the FDA scientists.
More importantly, under current laws, FDA can take approved products off the market only if there is a safety risk. So, most likely FDA will not do this. However, they could come back and limit the market under one pretext or another. Even that seems hard without a clear evidence to support it. If this were to happen, it is not just ReGen that would suffer, but the entire medical device industry, as it would prove once for all that getting FDA approval is not the end of the road to market.
While I am not sure if this is the first time, I am still hopeful. I am not sure if we would have ever heard about this case if the FDA Commissioner who oversaw this process had still been at the head of the Agency. The approval was done on December 20, 2008, right after the Presidential elections. The FDA commissioner resigned on January 20, 2009, and the FDA scientists wrote to the Congress in late January against their boss. This issue does not leave anyone untouched – the company, FDA scientists, politicians who used their influence, even FDA lawyers who did not advise in time, per their own internal review. This episode is certainly a case-study we will all review for a long time about the dos and don’ts of interacting with the US FDA.
Monday, April 19, 2010
Regulatory Updates
1. The FDA is announcing a public meeting for individuals and/or groups that might be interested in nominating voting and nonvoting consumer representatives to FDA advisory committees and panels. This public meeting also is for individuals who are interested in serving as voting and nonvoting representatives of FDA advisory committees and panels. The meeting will be head on April 30, 2010 at Food and Drug Administration, Center for Drug Evaluation and Research Advisory Committee in Rockville, MD.
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm206412.htm
2. On April 15, FDA launched FDA-TRACK (Transparency, Results, Accountability, Credibility and Knowledge-sharing), a performance management program that will monitor 100 FDA program offices through key performance measures. The goal of the program is to provide a closer look into how the FDA works, create more accountability within the offices, and share information about FDA performance.
http://www.fda.gov/AboutFDA/WhatWeDo/track/default.htm
3. FDA issued final guidance on a serialized numerical identifier (SNI) for prescription drug packaging. The guidance will provide companies with confidence their serialization efforts will comply with any future federal regulations.
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM206075.pdf
4. On April 19 the US Food and Drug Administration, Center for Devices and Radiological Health (CDRH), launched their Medical Device and Radiation-Emitting Product Transparency Web site. The agency launched this site as part of the agency’s transparency initiative. The site will provide information about medical device and radiation-emitting product regulatory processes and decisions and summaries of data that provide rationale for agency actions.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm208969.htm
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm206412.htm
2. On April 15, FDA launched FDA-TRACK (Transparency, Results, Accountability, Credibility and Knowledge-sharing), a performance management program that will monitor 100 FDA program offices through key performance measures. The goal of the program is to provide a closer look into how the FDA works, create more accountability within the offices, and share information about FDA performance.
http://www.fda.gov/AboutFDA/WhatWeDo/track/default.htm
3. FDA issued final guidance on a serialized numerical identifier (SNI) for prescription drug packaging. The guidance will provide companies with confidence their serialization efforts will comply with any future federal regulations.
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM206075.pdf
4. On April 19 the US Food and Drug Administration, Center for Devices and Radiological Health (CDRH), launched their Medical Device and Radiation-Emitting Product Transparency Web site. The agency launched this site as part of the agency’s transparency initiative. The site will provide information about medical device and radiation-emitting product regulatory processes and decisions and summaries of data that provide rationale for agency actions.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm208969.htm
Thursday, April 15, 2010
Several Changes to the 510k Review Process Expected Soon
The Food and Drug Administration announced at a public meeting in Feb, that it will propose major changes in May 2010 to several pathways for getting a medical device approved quickly. These include the “Special 510k” and the “Third-Party Review” programs. Over the last several years, concerns have been raised about whether the pathways available for rapid 510(k) clearance are overused and may be abused by the industry to get devices with suspect safety and efficacy in the market. In the last two years, after several internal discussions and Congressional inquiries, particularly after RaGen’s Menaflex episode, FDA has proposed to clarify key processes for 510k review.
Some major changes are expected regarding use of predicate devices. FDA indicated that it will establish a practice of allowing substantial equivalence to a single predicate. This would disallow the practice of “Multiple and Split Predicates” whereby a submitter uses more than one predicate devices to establish equivalence to different aspects of the same device. For example, one predicate may be used for the indication for use, and a second predicate for demonstrating substantial equivalence for the technology. The new device may be very different from either of the predicate devices when compared alone. The practice of using outdated predicates might also be out of the door soon as FDA does not feel that it is appropriate for a sponsor to use as predicate a device that is no longer is use and has been replaced by new technology. Some other industry practices are subject to stricter regulation such as “Predicate Creep” whereby incremental device changes that seem innocuous individually in one application may accumulate over time to create a device that is significantly different from the original device.
FDA is considering eliminating the Special 510(k) program, in which device makers can declare that their new device conforms to an earlier one they make except for a specific modification. The approval decision on Special 510(k) has to be made by the FDA within 30 days. Roughly a quarter of all 510(k) approvals go through the specials program. FDA reviewers often can't check the veracity of summaries made by companies in real time, and there had been at least one rescission of a special 510(k) device "based on false information." FDA thinks that this program should be eliminated and that all 501(k) applications, even for improvements made on a device made by the same manufacturer, be reviewed under the normal time lines.
Another issue of great concern for the FDA is the third-party review program. Third-party reviewers are FDA-approved private companies that are hired by device makers to pre-review products. If the third party signs off on the device, the FDA mostly approve it without much further scrutiny. FDA receives more than 300 applications every year through the third-party program. FDA is concerned that the third-party reviewers often lack expertise and "often just repeat what is in the submission" from the device company without analyzing it. As a possible solution, FDA is considering eliminating third party reviewers all together, limiting the type of devices they are allowed to review or giving the review companies more information on devices in order to educate them and improve their work.
Some other things in the regulatory pipeline are imposing postmarket surveillance studies as a condition of 510(k) clearance, allowing for the rescission of 510(k) clearance decisions under a broad range of circumstances, using available postmarket information in review of similar devices, reviewing and clearing the final printed labeling prior to marketing, and requiring reporting of any changes in ownership of a 510(k).
FDA agreed in the public meeting that it needs to increase transparency and achieve consistency in how it makes it decisions across different applications. In the next few months, FDA would be issuing recommendations for strengthening the 510(k) with a goal is to begin implementation of changes by September 30, 2010.
It is clear that FDA is not happy with the way things are and plans to make significant changes to the process in the near future. It is self-imposing strict and tight time-lines to propose and implement changes. Device manufacturers should follow the news very closely.
Some major changes are expected regarding use of predicate devices. FDA indicated that it will establish a practice of allowing substantial equivalence to a single predicate. This would disallow the practice of “Multiple and Split Predicates” whereby a submitter uses more than one predicate devices to establish equivalence to different aspects of the same device. For example, one predicate may be used for the indication for use, and a second predicate for demonstrating substantial equivalence for the technology. The new device may be very different from either of the predicate devices when compared alone. The practice of using outdated predicates might also be out of the door soon as FDA does not feel that it is appropriate for a sponsor to use as predicate a device that is no longer is use and has been replaced by new technology. Some other industry practices are subject to stricter regulation such as “Predicate Creep” whereby incremental device changes that seem innocuous individually in one application may accumulate over time to create a device that is significantly different from the original device.
FDA is considering eliminating the Special 510(k) program, in which device makers can declare that their new device conforms to an earlier one they make except for a specific modification. The approval decision on Special 510(k) has to be made by the FDA within 30 days. Roughly a quarter of all 510(k) approvals go through the specials program. FDA reviewers often can't check the veracity of summaries made by companies in real time, and there had been at least one rescission of a special 510(k) device "based on false information." FDA thinks that this program should be eliminated and that all 501(k) applications, even for improvements made on a device made by the same manufacturer, be reviewed under the normal time lines.
Another issue of great concern for the FDA is the third-party review program. Third-party reviewers are FDA-approved private companies that are hired by device makers to pre-review products. If the third party signs off on the device, the FDA mostly approve it without much further scrutiny. FDA receives more than 300 applications every year through the third-party program. FDA is concerned that the third-party reviewers often lack expertise and "often just repeat what is in the submission" from the device company without analyzing it. As a possible solution, FDA is considering eliminating third party reviewers all together, limiting the type of devices they are allowed to review or giving the review companies more information on devices in order to educate them and improve their work.
Some other things in the regulatory pipeline are imposing postmarket surveillance studies as a condition of 510(k) clearance, allowing for the rescission of 510(k) clearance decisions under a broad range of circumstances, using available postmarket information in review of similar devices, reviewing and clearing the final printed labeling prior to marketing, and requiring reporting of any changes in ownership of a 510(k).
FDA agreed in the public meeting that it needs to increase transparency and achieve consistency in how it makes it decisions across different applications. In the next few months, FDA would be issuing recommendations for strengthening the 510(k) with a goal is to begin implementation of changes by September 30, 2010.
It is clear that FDA is not happy with the way things are and plans to make significant changes to the process in the near future. It is self-imposing strict and tight time-lines to propose and implement changes. Device manufacturers should follow the news very closely.
Tuesday, April 6, 2010
How to Prepare for a “Surprise” Audit by the FDA
FDA audits are intimidating, more so when they happen by without advanced notice. Under the law, FDA conducts three kinds of audits; compliance audits before approval of a marketing application, for-cause or routine audits of manufacturing facilities, and “random surveillance” audits of facilities involved with FDA-regulated activities. The third kind are considered the rarest of them all since it is not practical for FDA to audit all facilities involved in activities regulated by it without having a good reason for the same. Unless you have an application under review by the FDA or are manufacturing a product, one is advised to not worry about FDA audits as the possibility of that happening is rare. So, you can imagine my anxiety when one day I get a call from someone introducing herself as an FDA inspector and informing that she would be visiting my facility for a “routine surveillance” inspection. FDA had picked names out of a hat and my company’s popped out. More importantly, she was not looking at any specific project but wanted to look at all the activities we do.
We are a contract research organization (CRO), i.e., at any given time we are involved in a many projects for many clients, from early stage Phase I trials, all the way to large Phase IV global studies. We work with drugs, biologics and devices. We could be doing various different things for a client, such as developing their clinical/non-clinical protocols, managing clinical operations, auditing their facilities, data management, FDA meetings and writing their reports or FDA submissions. Our activities are diverse and clientele spread all over the World. Unlike the other two kinds of audits, where FDA is looking for very specific information about one or few products, surveillance audits are very broad in scope. So, how to you prepare for such an audit? We have extensive well-defined processes and documentation to demonstrate compliance with the regulations. And we know that any facility involved in FDA-regulated activities should always be prepared for an audit like this.
A facility should have detailed SOPs, organizational chart listing the managers for each department, have good training processes for all personnel at the least on SOPs but preferably some broad training to demonstrate depth of knowledge, have documentation to demonstrate compliance with SOPs, have an independent QA department and processes for internal audit, and good documentation practices. Each manager should be able to not only describe all the SOPs in a simple layman terms but also explain the documentation accompanying each task. We called a meeting of all personnel to inform about the upcoming FDA audit and requested to review all the projects that they are involved in. QA was to be informed of any anomalies discovered. The audit prep is a detailed process for which we have a separate SOP and training process. So, we have always been prepared for such an audit.
The FDA inspector arrived on time, showed her credentials, and was escorted to the space reserved for audit activities. She presented the audit notification, FDA 482, and informed us that this audit was initially requested by the Medical Device regulators since we have represented several pivotal applications including PMAs and 501Ks for our clients. All our SOPs, organization chart and a list of the project completed or ongoing at our facility since the last three years were requested. From that the auditor randomly picked the SOPs she wanted to review in details (about 30), the people she wants to see training files for, and 6 projects for which she wanted to review documentation. The audit went smoothly. We had all our documents and people ready. All queries were addressed promptly and appropriately.
The audit was supposed to be done over two days but by 3Pm on Day 1, the auditor had already reviewed all she wanted to. And she had a lot of good things to say for us. She told us that our SOPs are some of best she has ever seen in her 20+ years as an auditor with our flow charts and assessment questionnaire being the stand-out features. She felt we were very organized as we had everything she needed to her in minutes. She felt our personnel were very experienced for what they were assigned.
How did we do that? Simple, make it easy for the auditor and it will pay dividends. Make the time to get the documents as short as possible, have personnel explain documents before handing over, have training records reflect not just the resume and qualifications but also all the extra things that companies pay for such a conference attendance, workshops attended, papers written, etc. More importantly, keep everyone’s nerves calm and atmosphere cordial.
The best advice, be prepared, always.
We are a contract research organization (CRO), i.e., at any given time we are involved in a many projects for many clients, from early stage Phase I trials, all the way to large Phase IV global studies. We work with drugs, biologics and devices. We could be doing various different things for a client, such as developing their clinical/non-clinical protocols, managing clinical operations, auditing their facilities, data management, FDA meetings and writing their reports or FDA submissions. Our activities are diverse and clientele spread all over the World. Unlike the other two kinds of audits, where FDA is looking for very specific information about one or few products, surveillance audits are very broad in scope. So, how to you prepare for such an audit? We have extensive well-defined processes and documentation to demonstrate compliance with the regulations. And we know that any facility involved in FDA-regulated activities should always be prepared for an audit like this.
A facility should have detailed SOPs, organizational chart listing the managers for each department, have good training processes for all personnel at the least on SOPs but preferably some broad training to demonstrate depth of knowledge, have documentation to demonstrate compliance with SOPs, have an independent QA department and processes for internal audit, and good documentation practices. Each manager should be able to not only describe all the SOPs in a simple layman terms but also explain the documentation accompanying each task. We called a meeting of all personnel to inform about the upcoming FDA audit and requested to review all the projects that they are involved in. QA was to be informed of any anomalies discovered. The audit prep is a detailed process for which we have a separate SOP and training process. So, we have always been prepared for such an audit.
The FDA inspector arrived on time, showed her credentials, and was escorted to the space reserved for audit activities. She presented the audit notification, FDA 482, and informed us that this audit was initially requested by the Medical Device regulators since we have represented several pivotal applications including PMAs and 501Ks for our clients. All our SOPs, organization chart and a list of the project completed or ongoing at our facility since the last three years were requested. From that the auditor randomly picked the SOPs she wanted to review in details (about 30), the people she wants to see training files for, and 6 projects for which she wanted to review documentation. The audit went smoothly. We had all our documents and people ready. All queries were addressed promptly and appropriately.
The audit was supposed to be done over two days but by 3Pm on Day 1, the auditor had already reviewed all she wanted to. And she had a lot of good things to say for us. She told us that our SOPs are some of best she has ever seen in her 20+ years as an auditor with our flow charts and assessment questionnaire being the stand-out features. She felt we were very organized as we had everything she needed to her in minutes. She felt our personnel were very experienced for what they were assigned.
How did we do that? Simple, make it easy for the auditor and it will pay dividends. Make the time to get the documents as short as possible, have personnel explain documents before handing over, have training records reflect not just the resume and qualifications but also all the extra things that companies pay for such a conference attendance, workshops attended, papers written, etc. More importantly, keep everyone’s nerves calm and atmosphere cordial.
The best advice, be prepared, always.
Friday, April 2, 2010
Regulatory Updates
1. On March 29, 2010 the FDA proposed an amendment to their regulations of direct-to-consumer (DTC) advertisements of prescription drugs. This proposed amendment would require that DTC ads dealing with side effects and contraindications of an advertised prescription drug be clear, conspicuous and in a neutral manner.
http://edocket.access.gpo.gov/2010/pdf/2010-6996.pdf
2. FDA announced this week that they are going to begin to require medical device manufacturers to include information in some premarket applications on pediatric patients who suffer from the disease or condition that the device is intended to treat, diagnose, or cure, even if the device is intended for adult use
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm206872.htm
3. A New York judge ruled that Myriad Genetics Inc.’s patents on BRCA1 and BRCA2 genes are invalid because they are naturally occurring, which may mean the end to all gene patents.
http://www.businessweek.com/news/2010-03-29/myriad-loses-ruling-over-breast-cancer-gene-patents-update1-.html
http://edocket.access.gpo.gov/2010/pdf/2010-6996.pdf
2. FDA announced this week that they are going to begin to require medical device manufacturers to include information in some premarket applications on pediatric patients who suffer from the disease or condition that the device is intended to treat, diagnose, or cure, even if the device is intended for adult use
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm206872.htm
3. A New York judge ruled that Myriad Genetics Inc.’s patents on BRCA1 and BRCA2 genes are invalid because they are naturally occurring, which may mean the end to all gene patents.
http://www.businessweek.com/news/2010-03-29/myriad-loses-ruling-over-breast-cancer-gene-patents-update1-.html
Friday, March 12, 2010
Regulatory News Update
1. In efforts to provide regulatory assistance to sponsors with potential drugs eligible for orphan drug designation status. The Office of Orphan Products Development (OOPD) hosted their first of two workshops February 25-26 in California and plan to host a second workshop on August 3-4 in Minnesota.
http://www.fda.gov/downloads/ForIndustry/DevelopingProductsforRareDiseasesConditions/UCM189586.pdf
2. Roughly $60 billion worth of drug patents in the world are going to expire within the next four years and Indian pharmaceutical companies are likely to be major players in generic manufacturing. India is the number one exporter of generic drugs and 60% of generic drugs are produced by Indian companies.
http://timesofindia.indiatimes.com/biz/india-business/Drug-patents-worth-60bn-to-expire-in-4-years/articleshow/5673545.cms
3. The Biotechnology Industry Organization asked Congress to support biotech chemical platforms to create green industry and job growth.
http://bio.org/news/pressreleases/newsitem.asp?id=2010_0311_01
http://www.fda.gov/downloads/ForIndustry/DevelopingProductsforRareDiseasesConditions/UCM189586.pdf
2. Roughly $60 billion worth of drug patents in the world are going to expire within the next four years and Indian pharmaceutical companies are likely to be major players in generic manufacturing. India is the number one exporter of generic drugs and 60% of generic drugs are produced by Indian companies.
http://timesofindia.indiatimes.com/biz/india-business/Drug-patents-worth-60bn-to-expire-in-4-years/articleshow/5673545.cms
3. The Biotechnology Industry Organization asked Congress to support biotech chemical platforms to create green industry and job growth.
http://bio.org/news/pressreleases/newsitem.asp?id=2010_0311_01
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