MAPS Public Benefit Corp. files what it calls the first NDA submission for a psychedelic-assisted therapy, MDMA (midomafetamine capsules), for use in ...
FDA says it is creating a nine-member Genetic Metabolic Diseases Advisory Committee.
Public Citizen calls on FDA to strengthen the Botox Boxed Warning to highlight the risk of systemic iatrogenic botulism and related symptoms.
FDA publishes a draft guidance on the Advanced Manufacturing Technologies Designation Program and its benefits for drug development.
Utah-based medical device company Dolor Technologies settles False Claims Act charges with the federal government over a device it sold for treating m...
FDA publishes a draft guidance with clinical pharmacology considerations to assist industry in developing peptide drug products.
CDER Office of Clinical Pharmacology policy lead Qin Sun uses a podcast to explain the agencys risk-based approach to evaluating drug-drug interaction...
Federal Register notice: CDER and CBER announce that support begins for version 2.0 of the Clinical Data Interchange Standards Consortium (CDISC) Stud...
