Mondaq USA: Food, Drugs, Healthcare, Life Sciences > Life Sciences, Biotechnology & Nanotechnology
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have been top of mind for policymakers in recent years.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation's abbreviated marketing pathway for biosimilar products
Morrison & Foerster LLP
In December, the U.S. Food and Drug Administration (FDA) issued guidance on Technical Considerations for Additive Manufactured Medical Devices.
Morgan Lewis
Amgen paints a different picture as to the bad actor during the parties' negotiations pursuant to the Biologics Price Competition and Innovation Act.
Fenwick & West LLP
Any patent plaintiff would be thrilled to get a ruling of infringement on summary judgment — but if that win ultimately resulted in zero damages, it would ring hollow.
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
The USPTO Checker Version 4.4.6 is a Microsoft Windows-based software application for checking biotechnology Sequence Listings for compliance with format and content rules.
Reed Smith
Having already issued our posts on the best and worst cases of 2017, we will resist the temptation to comment on the year as a whole, particularly on the powder keg that is politics.
Reed Smith
It's been 3 ½ years since we last updated our index to our online research resources.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
This is the third installment of our year-in-review series covering major developments at FDA. While the previous two installments, which can be found here and here, pertain to FDA actions ...
Reed Smith
Sometimes it happens. For eleven years, we have published our annual "worst of" the year post on the Thursday before Christmas and our annual "best of" the year post on the Thursday before New Year's.
Carlson, Caspers, Vandenburgh, Lindquist & Schuman, P.A.
Recently, the Federal Circuit reversed a jury decision upholding the validity of two Amgen patents directed to a large genus of antibodies that reduce LDL cholesterol.
Arnold & Porter Kaye Scholer LLP
The Final Guidance builds on a regulatory framework that CMS and FDA have developed in collaboration.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Yesterday we started off our year-end series of blog posts with the first part of a review of FDA's actions for 2017 in the therapeutic products space.
Arnold & Porter Kaye Scholer LLP
On December 7, 2017, the FDA announced several digital health policy documents designed to "encourage innovation" and "bring efficiency and modernization" to the agency's regulation of digital health products.
Reed Smith
The Food and Drug Administration (FDA) recently released new draft guidance documents to clarify its approach to regulating software as a medical device.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
In an opinion issued on December 14, 2017, the United States Court of Appeals for the Federal Circuit held that the 2010 Biologics Price Competition and Innovation Act ...
Wilson Elser Moskowitz Edelman & Dicker LLP
Previously on this blog, Wilson Elser attorneys have written several posts about 3D printing technology and the law. We have predicted that this new technology has the potential to change...
Ropes & Gray LLP
What are the legal implications of using social media and mobile applications in clinical trials and the recent developments impacting research fraud investigations?
Seyfarth Shaw LLP
The ability to facilitate the regeneration of parts of the human body is "no longer the stuff of science fiction" according to FDA Commissioner Scott Gottlieb.
Reed Smith
In Deluca v. Portland Orthopaedics Ltd., et al., 2017 U.S. Dist. LEXIS 198962 (E.D.N.Y. Dec. 2, 2017), a husband and wife sued for injuries relating to a failed hip implant. The husband and wife lived in New York.
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Morgan Lewis
Amgen paints a different picture as to the bad actor during the parties' negotiations pursuant to the Biologics Price Competition and Innovation Act.
Ropes & Gray LLP
What are the legal implications of using social media and mobile applications in clinical trials and the recent developments impacting research fraud investigations?
Carlson, Caspers, Vandenburgh, Lindquist & Schuman, P.A.
Recently, the Federal Circuit reversed a jury decision upholding the validity of two Amgen patents directed to a large genus of antibodies that reduce LDL cholesterol.
Arnold & Porter Kaye Scholer LLP
On December 7, 2017, the FDA announced several digital health policy documents designed to "encourage innovation" and "bring efficiency and modernization" to the agency's regulation of digital health products.
Reed Smith
Having already issued our posts on the best and worst cases of 2017, we will resist the temptation to comment on the year as a whole, particularly on the powder keg that is politics.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
This is the third installment of our year-in-review series covering major developments at FDA. While the previous two installments, which can be found here and here, pertain to FDA actions ...
Reed Smith
Sometimes it happens. For eleven years, we have published our annual "worst of" the year post on the Thursday before Christmas and our annual "best of" the year post on the Thursday before New Year's.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Yesterday we started off our year-end series of blog posts with the first part of a review of FDA's actions for 2017 in the therapeutic products space.
Wilson Elser Moskowitz Edelman & Dicker LLP
Previously on this blog, Wilson Elser attorneys have written several posts about 3D printing technology and the law. We have predicted that this new technology has the potential to change...
Arnold & Porter Kaye Scholer LLP
The Final Guidance builds on a regulatory framework that CMS and FDA have developed in collaboration.
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