Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 04 Jul 2017
Are drug regulators really too slow?
29 June 2017 - Regulators are often accused of delaying approval of new drugs by slow processes. Tom Marciniak and ...
Posted by Michael Wonder on 29 Jun 2017
FDA is reviewing generic applications faster, but what about those carryover fees?
28 June 2017 - Now that the FDA plans to fast-track generic drug applications in hopes of spurring competition and ...
Posted by Michael Wonder on 29 Jun 2017
FDA unveils plan to eliminate orphan designation backlog
29 June 2017 - Today, the U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency’s existing ...
Posted by Michael Wonder on 06 Apr 2017
Regulatory review of new therapeutic agents — FDA versus EMA (2011–2015)
6 April 2017 - The FDA faces continual pressure to accelerate the regulatory review and approval of new medicines. ...
Posted by Michael Wonder on 21 Mar 2017
Drug, device industries get one year delay on off label rule
20 March 2017 - The FDA is hitting the pause button on a recent rule affecting what drug and device ...
Posted by Michael Wonder on 11 Mar 2017
Radius Health receives notification of PDUFA extension for abaloparatide
10 March 2017 - PDUFA goal date extended by standard extension period of three months to 30 June 2017. ...