Blog
RSS FeedPosted by Michael Wonder on 08 Feb 2018
Glaxo's key drug gains time as FDA denies Novartis generic
8 February 2018 - Sandoz unit will provide agency with details on Advair copy. ...
Posted by Michael Wonder on 29 Jan 2018
FDA approved record number of generic drugs last year
26 January 2018 - The FDA approved 1,027 generic drugs last year, a record number, the Trump administration said Friday. ...
Posted by Michael Wonder on 16 Jan 2018
Statement from FDA Commissioner responding to report from GAO and updating on FDA’s ongoing efforts to increase access to complex generic drugs
16 January 2018 - Today the U.S. Government Accountability Office published a report titled “Generic Drugs: FDA Should Make Public ...
Posted by Michael Wonder on 08 Jan 2018
Plans to slash medical costs in America run into generic drug concerns
6 January 2018 - FDA generics push comes amid quality enforcement woes in India. ...
Posted by Michael Wonder on 03 Jan 2018
Statement from FDA Commissioner on new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices
3 January 2018 - The FDA today announced additional steps to encourage generic competition as part of our continued implementation of ...
Posted by Michael Wonder on 28 Dec 2017
Prices of generic drugs associated with numbers of manufacturers
28 December 2017 - Low-cost generic drugs have improved outcomes in patients while saving the health care system more than $1 ...
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 05 Dec 2017
This company is about to flood the U.S. with cheap HIV drugs
5 December 2017 - Patents on key branded medicines to start expiring soon. ...
Posted by Michael Wonder on 04 Dec 2017
Encouraging new uses for old drugs
4 December 2017 - US FDA approval of a new drug typically coincides with a period of patent protection, during which ...
Posted by Michael Wonder on 21 Nov 2017
Statement from FDA Commissioner on steps to promote development of generic versions of opioids formulated to deter abuse
21 November 2017 - FDA issues guidance on development of generic abuse-deterrent opioids. ...
Posted by Michael Wonder on 13 Nov 2017
High costs of FDA approval for formerly unapproved marketed drugs
13 November 2017 - In May 2017, the US FDA announced a Drug Competition Action Plan, designed to address competition and ...
Posted by Michael Wonder on 08 Nov 2017
Statement from FDA Commissioner Scott Gottlieb on new steps to improve FDA review of shared Risk Evaluation and Mitigation Strategies to improve generic drug access
8 November 2017 - New FDA draft guidance to streamline the submission and review process for shared system REMS. ...
Posted by Michael Wonder on 17 Oct 2017
Generic drug user fees reauthorisation: a victory for public health
17 October 2017 - We marked an important milestone in the U.S. generic drug program on 1 October 2017 – the ...
Posted by Michael Wonder on 13 Oct 2017
A ‘holy cow’ moment: the FDA approved a record number of generics
12 October 2017 - As the FDA attempts to foster more competition in the prescription drug market, the agency appears ...
Posted by Michael Wonder on 11 Oct 2017
An FDA program to approve old drugs causes higher prices and shortages
11 October 2017 - In 2006, the FDA launched a program to require drug makers to win approval of medicines ...