FDA releases its latest batch of Warning Letters that includes one medical product company LifeHealth Science.
FDA Review posts product approval summaries for the week ending 5/29/2020.
CDER issues its fifth annual drug safety priorities report detailing the effort at multidisciplinary collaboration in the Center.
Federal Register notice: FDA provides notification that it approved a drug product that relied on a priority review voucher for approval Biohaven Pha...
FDA approves an Avid Radiopharmaceuticals NDA for Tauvid (flortaucipir F18) for intravenous injection, the first drug for helping image a distinctive ...
Federal Register notice: FDA makes available a final guidance #240 entitled Proprietary Names for New Animal Drugs.
FDA provides a voluntary EUA template for device developers to use for Covid-19 at-home sample collection kits.
FDA says five drug firms will need to recall their metformin drug products after sampling detected an impurity (N-Nitrosodimethylamine) above the agen...