Lawmakers introduce bipartisan legislation in the House and Senate to provide a skinny label safe harbor for certain human and animal drugs.
FDA warns Montague, MI-based Tower Laboratories about CGMP violations in its manufacture of finished drugs.
FDA warns Tampa, FL-based LiquidCapsule Manufacturing about repeated CGMP violations in its production of finished drugs.
FDA publishes digital health guidances relating to low-risk general wellness products and clinical decision support software.
FDA posts a guidance on Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, D...
FDA releases substantive Warning Letters in the last two weeks of December 2025.
FDA releases the form FDA-483 with three observations from an inspection at the Sun Pharmaceutical Medicare sterile drug manufacturing facility in Hal...
A Hyman, Phelps & McNamara CMC regulatory expert lists the initial industry recommendations for improvements to be negotiated in the BsUFA reauthoriza...
