FDA issues Warning Letters to two online marketers promoting unapproved glucagon-like peptide-1 receptor agonists semaglutide and tirzepatide.
Three stakeholder organizations suggest changes to an FDA draft guidance on postmarketing approaches to obtain data on populations underrepresented in...
FDA releases the form FDA-483 with 14 observations from an inspection at the New Brunswick, NJ-based Spectrum Laboratory Products repacking/relabeling...
FDA publishes minor updates to two magnetic resonance guidances to harmonize them with the latest consensus standards.
FDA warns Miami, FL-based Dr. Antonio Blanco/Vista Health Research about conducting two clinical investigations in a way that did not follow the inves...
FDA lists several cautions it says patients and healthcare providers should be aware of when considering using compounded ketamine products to treat c...
The National Center for Health Research says an FDA draft guidance on QTc information in drug and biologic labeling is too vague to be useful and reco...
CDRH publishes a list of final and draft guidances to be published in FY 2024.
