Federal Register notice: FDA withdraws approval of 21 ANDAs from multiple applicants after they notified the agency that the products were no longer m...
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances.
Federal Register notice: FDA makes available a draft guidance entitled Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subjec...
FDA announces a 6/14 Webinar to share information and answer questions about its recent draft guidance entitled Cybersecurity in Medical Devices: Qual...
FDA approves Regenerons Dupixent (dupilumab) for treating eosinophilic esophagitis in adults and pediatric patients 12 years and older.
House Energy and Commerce Committee Republican leaders ask FDA commissioner Robert Califf to answer questions about a growing trend for clinical trial...
FDA publishes a draft guidance on possible enforcement discretion so dietary supplement companies can correct past failures to submit required new die...
CDER Office of Pharmaceutical Quality director Michael Kopcha says the agency is working on regulations to help companies become more comfortable with...