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.
FDA accepts for review a Supernus Pharmaceuticals supplemental NDA for Qelbree (viloxazine extended-release capsules) for treating attention-deficit h...
FDA clears a Molekule 510(k) for its existing air purifier, Air Pro, classifying it as a Class 2 medical device for medical use for the destruction of...