FDA publishes a Study Data Technical Conformance Guide with specifications, recommendations, and general considerations on how to submit standardized ...
Four pharmaceutical stakeholders recommend changes to an FDA question-and-answer draft guidance on electronic systems, records, and signatures.
FDA orders safety labeling changes for prescription stimulants used to treat attention deficit/hyperactivity disorder and other conditions.
Federal Register notice: FDA announces a 6/16 Oncologic Drugs Advisory Committee meeting of its Pediatric Oncology Subcommittee that will discuss dosa...
Federal Register notice: FDA releases a final guidance on drug testing for high-risk drug components.
Federal Register notice: FDA announces the revocation of three emergency use authorizations (EUAs) for Covid-19 tests because they are no longer being...
CDER director Patrizia Cavazzoni says the Center is working with CBER and CDRH on discussion papers involving artificial intelligence/machine learning...
FDA medical reviewers question the effectiveness and safety of Sareptas SRP-9001 as a treatment for some cases of Duchenne muscular dystrophy and ask ...
