Par Pharmaceutical recalls one lot of treprostinil injection due to the potential for the presence of silicone particulates in the product solution.
Federal Register notice: FDA seeks comments on a new proposed information collection entitled Proposed Small Dispensers Assessment Under the Drug Supp...
Federal Register notice: FDA makes available a draft guidance entitled Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug ...
Federal Register notice: FDA makes available a draft guidance entitled Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD...
Federal Register notice: FDA renews its Pharmaceutical Science and Clinical Pharmacology Advisory Committee for an additional two years.
A Hyman, Phelps & McNamara medical device regulatory expert and attorney say FDA should help industry learn how to avoid labs that produce fraudulent ...
FDA warns Gainesville, FL-based Exactech about Quality System and Medical Device Report violations in its manufacturing of orthopedic implants and acc...
FDA publishes a draft guidance with recommendations for NDA and ANDA applicants for nonprescription drugs to document minor labeling changes.
