On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
Update: Government Files Brief Seeking Dismissal of KV’s Lawsuit
- KV lacks standing to sue because, in June 2012—prior to KV filing suit—the agency posted on its website a statement and a Q&A advising pharmacies FDA may take enforcement action against pharmacies whose compounding of 17P exceeds the scope of traditional pharmacy practice, and this statement supersedes FDA’s March 2011 statement regarding the compounding of 17P (which KV challenged);
- FDA’s March 2011 statement is not subject to judicial review because decisions not to take enforcement action are committed to agency discretion under long-standing precedent. Heckler v. Chaney, 470 U.S. 821 (1985);
- FDA’s statement expressing intent to exercise enforcement discretion does not violate any of the sections of the FDC Act cited by KV; and
- An injunction is not proper because the agency’s testing of samples of compounded 17P and API failed to reveal any major safety concern, thus, an injunction would be inappropriate and contrary to the public interest.
In support of FDA’s position, Alere Women’s and Children’s Health, LLC, and a group of interested physicians also filed an amicus brief on July 24, 2012.
KV’s reply brief is due by July 27, 2012, and the government’s is due by August 3, 2012. The hearing on the motions remains scheduled for August 7, 2012—which interestingly is three days prior to the date (August 10, 2012) that FDA must file the Administrative Record with the Court.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017