Blog
RSS FeedPosted by Michael Wonder on 25 Apr 2018
Efficacy, safety, and regulatory approval of FDA–designated breakthrough and non-breakthrough cancer medicines
24 April 2018 - The breakthrough therapy program was established in 2012 to expedite the development and review of new medicines. ...
Posted by Michael Wonder on 18 Apr 2018
FDA official insists U.S. is catching up to Europe on biosimilar regulations, approvals
17 April 2018 - The FDA lags behind its European counterpart when it comes to approving biosimilars — but a ...
Posted by Michael Wonder on 05 Mar 2018
Accelerated approval in oncology: FDA touts successes, responds to criticism
5 March 2018 - A majority of oncology treatments granted accelerated approval over the last 25 years have gone on ...
Posted by Michael Wonder on 01 Mar 2018
Allergan announces FDA has extended the ulipristal acetate NDA review period to August 2018
1 March 2018 - Allergan today announced that it was notified by the U.S. FDA that the review of the new ...
Posted by Michael Wonder on 24 Feb 2018
FDA approves drugs before EMA and Swissmedic, comparison finds
23 February 2018 - From 2007 to 2016, the US FDA approved more new drugs and biologics first than its ...
Posted by Michael Wonder on 31 Jan 2018
New drugs, but slow access — here's how to speed breakthroughs to patients
30 January 2018 - The U.S. FDA approved 46 novel drugs in 2017, a 21-year high. However, it could take ...
Posted by Michael Wonder on 07 Dec 2017
FDA seeks to speed approvals of generic drug-device combos
5 December 2017 - New FDA guidance will make it easier for generic companies to get drug-device combination products approved. ...
Posted by Michael Wonder on 07 Dec 2017
Speed, safety, and industry funding - from PDUFA I to PDUFA VI
7 December 2017 - The FDA Reauthorization Act of 2017 includes the sixth version of the Prescription Drug User Fee Act. ...
Posted by Michael Wonder on 01 Dec 2017
FDA aims to expand early approval program for promising drugs
30 November 2017 - Scott Gottlieb speaks before House subcommittee on health. ...
Posted by Michael Wonder on 18 Nov 2017
U.S. FDA extends review for Tlando; Advisory Committee meeting date of 10 January 2018 remains unchanged
17 November 2017 - Lipocine today announced the U.S. FDA has extended the review period for the new drug application ...
Posted by Michael Wonder on 15 Nov 2017
Janet Woodcock wants you to know the FDA is not picking speed over safety in drug approvals
14 November 2017 - What is the biggest difference in working at the FDA under its new commissioner, Scott Gottlieb? ...
Posted by Michael Wonder on 14 Nov 2017
Theratechnologies announces decision by the FDA to extend the ibalizumab review period to 3 April 2018
13 November 2017 - Theratechnologies announced that it was notified today by its partner, TaiMed Biologics that the U.S. FDA ...
Posted by Michael Wonder on 18 Sep 2017
Strategies that delay market entry of generic drugs
18 September 2017 - Increasing prescription drug expenditures in the United States are primarily driven by high brand-name drug prices. Although ...
Posted by Michael Wonder on 20 Jul 2017
FDA may publicly shame drug makers for thwarting generic rivals
19 July 2017 - Attention brand-name drug makers: the FDA may soon publicly shame you for thwarting generic rivals. ...
Posted by Michael Wonder on 11 Jul 2017
FDA speeding generic drug approvals: not just lip service
10 July 2017 - May and June 2017 have seen the most generic drug approvals since the US FDA began ...