Agilis Consulting names former FDA human factors team leader Shannon Hoste as president.
An FDA/HHS-funded University of Maryland study identifies factors that it says can lead to an uninterrupted supply of drugs for the U.S.
Johnson & Johnson files data to support an emergency use authorization for its Covid-19 booster shot in those 18 years of age and older.
FDA revises four guidance documents based on a final rule on the medical device de novo classification process.
AstraZeneca applies for an FDA emergency use authorization for a long-acting antibody combination as a Covid-19 prophylaxis.
FDA says Medtronic has expanded its recall of insulin pump remote controllers due to cybersecurity risks.
FDA releases a report calling for accelerating the adoption of advanced and smart manufacturing technologies.
Federal Register notice: FDA withdraws a 9/30 notice that announced in error the issuance of a priority review voucher to a rare pediatric disease pro...