The Stericycle recall index for the third quarter of 2020 finds that drug recalls nearly doubled, while medical device recalls fell by one-third.
FDA issues a draft guidance with additional questions and answers on biosimilar development and the Biologics Price Competition and Innovation Act.
FDA has accepted for review an Alvotech USA BLA for a Humira biosimilar.
Pfizer and BioNTech plan to submit within days an Emergency Use Authorization request for their Covid-19 vaccine candidate BNT162b2 after a final anal...
Federal Register notice: FDA seeks comments on an information collection extension entitled Expedited Programs for Serious Conditions Drugs and Biolo...
Federal Register notice: FDA sends to OMB an information collection revision related to the registration of human drug compounding outsourcing facilit...
The HHS Inspector General says drug and device companies and healthcare professionals should weigh the risks when considering whether to participate i...
Federal Register notice: FDA corrects a notice that appeared in the 1/8 Federal Register announcing the approval withdrawals for 19 NDAs from multiple...