Blog
RSS FeedPosted by Michael Wonder on 20 Nov 2019
Generic drug approvals soar, but patients still go without
19 November 2019 - Brand name makers’ patent action limits release of the lower-price medicines, hindering cost-control efforts. ...
Posted by Michael Wonder on 17 Oct 2019
Have FDA actions to ease generic drug shortages taken effect yet?
16 October 2019 - On Wednesday, the FDA said fiscal year 2018 saw a record number of generic drug approvals. ...
Posted by Michael Wonder on 16 Oct 2019
Statement on continued progress enhancing patient access to high-quality, low-cost generic drugs
16 October 2019 - FDA generic drug approvals reach record high in fiscal year 2019. ...
Posted by Michael Wonder on 14 Oct 2019
FDA bid to bolster generic competition and combat shortages isn’t working — yet
14 October 2019 - Although the FDA has maintained that additional generic approvals should promote competition and alleviate shortages, the ...
Posted by Michael Wonder on 12 Oct 2019
Have FDA’s generic approvals helped with competition? Researchers say too early to tell
11 October 2019 - Amid increasing abbreviated new drug application approvals, efforts by the US FDA to promote generic drug development ...
Posted by Michael Wonder on 16 Sep 2019
FDA seeks input on product-specific guidances to facilitate generic drug development
16 September 2019 - Today, FDA published 53 product-specific guidances (PSGs) – 34 new guidances and 19 revised guidances, including ...
Posted by Michael Wonder on 29 Aug 2019
U.S. FDA approves Mylan generic of Lilly lung cancer drug Alimta
29 August 2019 - The U.S. Food and Drug Administration on Thursday granted Mylan tentative approval for its generic version ...
Posted by Michael Wonder on 20 Aug 2019
Sarepta Therapeutics receives complete response letter from the US FDA for golodirsen new drug application
19 August 2019 - Sarepta Therapeutics today announced it had received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 15 Aug 2019
Growing numbers of priority and competitive ANDAs under review as approvals trickle in
15 August 2019 - The US FDA on Wednesday released quarterly data on two of its programs aimed at increasing generic ...
Posted by Michael Wonder on 07 Aug 2019
FDA should take additional steps to address factors that may affect approval rates in the first review cycle
7 August 2019 - Companies that make generic drugs—which have the same active ingredients as brand-name drugs—have to apply for ...
Posted by Michael Wonder on 30 Jul 2019
Reforms to the generic medicine market authorisation process
30 July 2019 - The TGA would like to thank respondents who provided submissions in response to the public consultation ...
Posted by Michael Wonder on 22 Jul 2019
FDA approves first generics of Lyrica
22 July 2019 - On July 19, the U.S. FDA approved multiple applications for first generics of Lyrica (pregabalin) for the ...
Posted by Michael Wonder on 16 Jul 2019
Why isn’t insulin a complex generic? PA representative asks the FDA
16 July 2019 - Republican Mike Kelly (R-PA) sent a letter Tuesday to US FDA Acting Commissioner Ned Sharpless questioning ...
Posted by Michael Wonder on 10 Jul 2019
FDA announces new efforts to expedite generic drug development and marketing to improve patient access to medicines
10 July 2019 - Today, the U.S. FDA announced a draft guidance, Harmonizing Compendial Standards With Drug Application Approval Using the ...
Posted by Michael Wonder on 18 Jun 2019
FDA releases new data to help generic drug competitors
18 June 2019 - Generic drug applicants will now have more information from the US FDA when deciding whether to ...