Spotlight on CDER Science
FDA scientists carry out laboratory, clinical and analytical research to address knowledge gaps in drug development, healthcare technologies and post-market…
CDER Communications Testing: Optimizing Drug Information Through Target Audience Feedback
Social and behavioral scientists in CDER’s Office of Communications (OCOMM) collect feedback from target audience members on a variety of…
FDA Drug Safety Communication: FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women
Repeated or lengthy use of general anesthetic and sedation drugs in children younger than 3 years or in pregnant women…
FDA Drug Safety Communication: FDA review finds no significant increase in risk of serious asthma outcomes with long-acting beta agonists (LABAs) used in combination with inhaled corticosteroids (ICS)
A U.S. Food and Drug Administration (FDA) review of four large clinical safety trials shows that treating asthma with long-acting…
Bioiberica, SAU – 629115 – 01/15/2025
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Bioiberica, SAU – 629115 – 06/30/2022
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Administration Studies in Equine Antidoping Research: Designing Scientific Investigations to Effectively Direct Medication Control in Racehorses
ABSTRACT Pharmacokinetics is the study of the movement of drug in the body and includes the processes of absorption, distribution,…
Registered Outsourcing Facilities
Discover FDA’s comprehensive list of registered outsourcing facilities engaged in human drug compounding. Get the latest updates, compliance guidelines, and…
PDUFA Performance Reports
PDUFA Performance Reports
Industry Information and Guidance
FDA review of biosimilar and interchangeable products requires a 351(k) biologics license application that includes information demonstrating biosimilarity.