Federal Register notice: FDA reopens the comment period for a 6/8 draft guidance on demonstrating bioequivalence for Type A medicated articles.
Three CDER researchers share best practices to reduce deficiencies in regulatory submissions involving real-time release testing for dissolution and/o...
FDA warns Lincoln, RI-based Denison Pharmaceuticals about CGMP violations and manufacturing unapproved new drugs.
A new CDRH Web page on tips for providing stakeholder comments on guidance documents says the Center prefers comments that are submitted in a table fo...
FDA clears a CathVision 510(k) for the PVI Analyzer and Signal Complexity algorithms as part of the companys electrophysiology recording system.
The CDER Office of Prescription Drug Promotion warns AstraZeneca that a sales aid for its Breztri misrepresents the drugs efficacy.
FDA publishes a guidance on the roles of IRBs, clinical investigators, sponsors, and FDA in informed consent for clinical investigations.
FDA warns Boston, MA-based TEI Biosciences about Quality System violations in its manufacturing of collagen-based products.
