FDA denies an Insys Therapeutics petition asking for restrictions on ANDAs for a generic form of its Syndros.
FDA publishes an International Conference on Harmonization addendum to a 2000 guidance on clinical investigation of medicinal products in the pediatri...
FDA says the Custom Ultrasonics System 83 Plus automated endoscope reprocessor has been validated to effectively disinfect and Olympus and a Pentax du...
FDA releases an FDA-483 with three observations from an inspection at Indias Alembic Pharmaceuticals.
FDA approves a Pacira Pharmaceuticals NDA for Exparel (bupivacaine liposome injectable suspension) for expanded use as an interscalene brachial plexus...
Federal Register notice: FDA makes available a draft guidance on Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs....
Federal Register notice: FDA makes available a draft guidance on Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trial...
Federal Register notice: FDA requests comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling cha...