|September 22, 2014 -- Duane Morris Life Sciences Law Blog
FDA Goes Purple on Biosimilars: A Variation on a Theme of Orange. FDA announces biologics answer to the Orange Book's
listing of NDAs for small molecules even before any approval of a biosimilar under the Biologics Price Competition and
Innovation Act. For our analysis, read the blog entry, click here.
February 11, 2014 -- Duane Morris Life Sciences Law Blog
Two Federal Appeals Court Proceedings May Impact Patent and Regulatory Strategies for Developers of Stem Cell Technologies
Two recent proceedings at in separate circuits of the federal courts of appeal may impact the patent and regulatory strategies
essential for successful development of stem cell technologies. Indeed, a key impact of the two cases will be the need for both
early and careful coordination between a company's patent portfolio claims and parallel statements made to FDA to ensure that
the firm enhances its potential for success in each arena. To read the blog entry, click here.
October 5, 2013 -- Posted on LinkedIN
How the Government Shutdown is Impacting FDA -- on October 4, FDA posted a lengthy discussion on the CDER website on the
impact of the government shutdown on FDA operations, which is attached here. Persons interested in details on life with FDA
during the shutdown, should read the posting with care. Oddly, several hours later, that posting was no longer on the CDER
website, replaced with a much shorter posting, at http://www.fda.gov/Drugs/ucm370582.htm.
November 15, 2012 -- Posted on LinkedIN
Challenges of bringing mHealth products to the market are highlighted in Duane Morris mHealth Practice Group's latest
newsletter, including my article on an FDA-friendly avenue to commercialization. To read the newsletter, click here ...
November 3, 2012 -- Posted on LinkedIN
uniQure of the Netherlands for EU approval of its gene therapy for familial hyperchylomicronemia, a very rare disease. First gene
therapy approval in either the EU or U.S. For more information, click here ...
August 23, 2012 -- Posted on LinkedIN
FDA issues draft guidances on Generic Drug User Fee Act -- also calls for public meeting on user fees. To access the Guidances August 13, 2012 -- Posted on LinkedIN
and related Federal Register notices, click here ...
FDA issues draft guidance on “Refuse to Accept Policy for 510(k)s.” Guidance includes three detailed checklists – one each for
Traditional, Abbreviated and Special 510(k)s -- that all device firms should review to ensure your submissions are complete. For
copy of guidance, click here...
August 8, 2012 -- Posted on LinkedIN and www.duanemorris.com
D.C. Circuit's July 27 decision in Friedman v. Sebelius upholds HHS order excluding three ex-Purdue Pharma executives--including July 24, 2012 -- Posted on LinkedIN
ex-General Counsel--from federal healthcare programs. Decision highlights severe legal risks faced by officials at FDA-regulated
firms under the strict liability tenets of the Responsible Corporate Official (RCO) doctrine articulated in U.S. v. Park (1975 U.S.
Supreme Court decision). For a copy of our firm's alert on this key decision, which I penned, click here ...
Third Circuit Holds That Settlement Agreements Containing Payments from the Innovator to the Generic Challenger May Violate
Antitrust Laws. Creates split in federal circuits. For a copy of our firm's alert on this key decision, click here...
July 12, 2012 -- Posted on LinkedIN
FDA "Pre-Subbing" New Meeting System for Medical Devices -- new draft guidance to be announced tomorrow details in's and
out's of getting and supporting meeting requests for medical device. For copy of guidance, click here...