19 November 2019 - Brand name makers’ patent action limits release of the lower-price medicines, hindering cost-control efforts. ...
16 October 2019 - On Wednesday, the FDA said fiscal year 2018 saw a record number of generic drug approvals. ...
16 October 2019 - FDA generic drug approvals reach record high in fiscal year 2019. ...
14 October 2019 - Although the FDA has maintained that additional generic approvals should promote competition and alleviate shortages, the ...
11 October 2019 - Amid increasing abbreviated new drug application approvals, efforts by the US FDA to promote generic drug development ...
16 September 2019 - Today, FDA published 53 product-specific guidances (PSGs) – 34 new guidances and 19 revised guidances, including ...
29 August 2019 - The U.S. Food and Drug Administration on Thursday granted Mylan tentative approval for its generic version ...
19 August 2019 - Sarepta Therapeutics today announced it had received a complete response letter from the U.S. FDA regarding ...
15 August 2019 - The US FDA on Wednesday released quarterly data on two of its programs aimed at increasing generic ...
7 August 2019 - Companies that make generic drugs—which have the same active ingredients as brand-name drugs—have to apply for ...
30 July 2019 - The TGA would like to thank respondents who provided submissions in response to the public consultation ...
22 July 2019 - On July 19, the U.S. FDA approved multiple applications for first generics of Lyrica (pregabalin) for the ...
16 July 2019 - Republican Mike Kelly (R-PA) sent a letter Tuesday to US FDA Acting Commissioner Ned Sharpless questioning ...
10 July 2019 - Today, the U.S. FDA announced a draft guidance, Harmonizing Compendial Standards With Drug Application Approval Using the ...
18 June 2019 - Generic drug applicants will now have more information from the US FDA when deciding whether to ...