Attorney Sara Koblitz says the generic drug industry has been upended by a Federal Circuit Court of Appeals ruling that Teva induced infringement of a...
FDA releases the FDA-483 with 10 observations from an inspection at Japans Toyobo Co.
FDA Revire posts the Federal Register notices for the week ending 9/3/2021.
FDA review posts product approval summaries for the week ending 9/3/2021.
Federal Register notice: FDA renews its National Mammography Quality Assurance Advisory Committee for an additional two years beyond its charter expir...
FDA cautions that it may only be able to give the green light for booster shots later this month to those vaccinated with the Pfizer/BioNTech Covid-19...
Federal Register notice: A 10/28 advisory committee discusses whether an accelerated approval for an Oncopeptides NDA for Pepaxto (melphalan flufenami...
HHS restores FDAs authority to issues regulations without HHS authority, which was removed late in the Trump Administration.