Federal Register notice: FDA issues an order to debar for 10 years Thomas J. Whalen from importing or offering for import any drug into the U.S.
CDERs Office of New Drugs says approval standards are unchanged, reacting to concerns about a raft of negative drug review decisions.
FDA approves a Medtronic PMA for its Harmony Transcatheter Pulmonary Valve, the first minimally invasive therapy to treat patients with a specific typ...
FDA asks for changes to Benzedrex OTC decongestant inhalers to reduce the likelihood of abuse and misuse.
Alembic Pharmaceuticals recalls one lot of telmisartan tablets, USP, 20 mg, packaged in 30-count bottles due to a mislabeling concern.
AstraZeneca revises its Covid-19 clinical trial vaccine efficacy rate from 79% to 76% under a primary analysis after the studys data and safety monito...
CDER and the Critical Path Institute say they are launching an acute kidney injury project to develop prognostic tools.
FDA republishes OTC monograph user fees for FY 2021 to exclude some facilities producing hand sanitizer during the pandemic.