The U.S. Food and Drug Administration (FDA) is a federal agency within the U.S. Department of Health and Human Services responsible for protecting public health by regulating a broad range of products: human and veterinary drugs, biologics and vaccines, medical devices, the nation’s food supply, dietary supplements, cosmetics, radiation‑emitting products, and tobacco. Key centers include CDER (drugs), CBER (biologics), CDRH (devices and radiological health), CFSAN (food and cosmetics), and CTP (tobacco).
For the chemical industry, the FDA sets and enforces standards that shape product development, manufacturing, and market access. The agency reviews New Drug Applications and Abbreviated New Drug Applications, assesses active pharmaceutical ingredients and excipients, oversees current Good Manufacturing Practices (cGMP), and evaluates impurities, stability, and quality systems. It regulates food and color additives, food‑contact substances, and labeling, and oversees cosmetics safety under evolving authorities. The FDA issues guidance, conducts facility inspections, manages recalls and import alerts, and monitors post‑market safety. It collaborates with international bodies and aligns with global quality and safety frameworks to support consistent, science‑based regulation across the supply chain.
None yet. When a new project in the record names FDA as owner, partner or investor, it shows here.
evERA Phase III: giredestrant+everolimus doubled median PFS in ESR1‑mutated patients and improved ITT PFS; OS immature; manageable safety; FDA review dates set for Nov 30 and Dec 18, 2026.
Single CARVYKTI infusion produced treatment-free, progression-free remissions at five years in half of early-line relapsed/refractory multiple myeloma patients.
CHMP backs ocrelizumab for relapsing MS in patients aged 10 and older after Phase III showed stronger lesion suppression and comparable relapse control versus fingolimod.
FDA granted priority review to an oral TYK2 inhibitor after Phase 3 data from nearly 3,000 patients showed rapid, durable skin clearance; PDUFA target Q1 2027.
FDA accepted the application for satralizumab for adult and adolescent MOGAD and granted Priority Review with a decision due 10 Jan 2027; EMA validated the MAA, EC decision expected Q3 2027.
Priority Review follows Phase III METEOROID showing 68% relapse risk reduction; FDA decision expected Jan 10, 2027; EMA validated the MOGAD filing with EC decision due Q3 2027.
Phase 2 data show FcRn blocker nipocalimab reduced SLE activity versus placebo, with larger benefit in autoantibody‑positive patients and no new safety signals.
Oral semaglutide tablet now available in UAE for weight management; shows ~17% mean weight loss in trials and is approved to reduce certain cardiovascular risks.
