Quality

FDA
Manufacturing

FDA clarifies Form 483 expectations after production inspections

The FDA earlier this year unveiled, for the first time, draft guidance on best practices for the industry when replying to the receipt of a Form 483.
Fraiser Kansteiner May 1, 2026 10:52am
Bivigam

ADMA Biologics returning Bivigam to market after 3-year absence

May 13, 2019 9:35am
China flag

China slaps $1.3B penalty on vaccine scandal culprit

Oct 16, 2018 10:53am
vials

Sanofi's Riboldi talks up new facility's role in flu-shot push

Aug 7, 2017 11:22am
FDA

Request for a pause may kill FDA quality metrics proposal

Apr 10, 2017 11:38am
Wockhardts India headquarters building

Wockhardt management lambasted by FDA for 'repeated failures'

Mar 8, 2017 3:04pm