Categories

  • Innovation – Office of Science and Innovation, pharmaceutical innovation, health care innovations, new drug development, new molecular entities (NME), NME approvals, speeding access to new therapies, access to investigational drugs and other topics.
  • Regulatory Science – Office of the Chief Scientist, Strategic Plan for Regulatory Science, evaluation of new technologies, modernizing toxicology, cell therapy, tissue engineering, genomics, personalized medicine, using data, developing medical countermeasures to protect against security threats and other issues.
  • Globalization – Office of Global Regulatory Operations and Policy, global collaboration on international product quality and safety, global data sharing, development of global safety standards, FDA field activities abroad and other globalization topics.
  • Food – Center for Food Safety and Applied Nutrition, including FSMA, food recalls, cosmetics, dietary supplements, food enforcement actions, genetically engineered animals, nutrition labeling and seafood.
  • Drugs – Center for Drug Evaluation and Research, including Adverse Event Reporting System, Biosimilars, drug approval process, drug approval statistics, drug enforcement actions, generic drugs, over-the-counter drugs, personalized medicine, prescription drug advertising, PDUFA.
  • Medical Devices / Radiation-Emitting Products – Center for Devices and Radiological Health, including 510K/premarket approval, CDRH Innovation Initiative, device enforcement actions, direct-to-consumer genetic tests and laboratory-developed tests, LASIK, medical device adverse event reporting, MDUFA, radiation exposure.
  • Vaccines, Blood & Biologics – Center for Biologics Evaluation and Research, including blood and vaccines.
  • Animal & Veterinary – Center for Veterinary Medicine, including pet food.
  • Tobacco Products – Center for Tobacco Products.
  • Other Topics – Including clinical trials, National Center for Toxicological Research (NCTR), orphan products, and all other topics.