Pharmaceutical Research and Manufacturers of America says FDA should allow drug companies to seek waivers from the one-page patient medication informa...
FDA accepts for review an Xcovery Holdings NDA for ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor for treating adult patients with metastat...
Federal Register notice: FDA seeks comments on a new proposed information collection entitled Proposed Small Dispensers Assessment Under the Drug Supp...
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Federal Register notice: FDA makes available a draft guidance entitled Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug ...
Federal Register notice: FDA makes available a draft guidance entitled Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD...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.
