In observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Tuesday, July 6.
FDA posts a draft guidance on Sponsor Responsibilities Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence...
Federal Register notice: FDA seeks comments on a proposed information collection entitled Class II Special Controls for Human Immunodeficiency Virus ...
Federal Register notice: FDA sends to OMB an information collection extension entitled Prescription Drug Marketing; Administrative Procedures, Policie...
A House Appropriations Subcommittee approves by voice vote FDAs s fiscal year 2022 budget bill that would increase the agencys budget by $257 million ...
Avid Medical recalls (Class 1) medical convenience kits that include the BD/Carefusion Chloraprep 3mL applicator due to the risk of contamination with...
Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Approach to Available Therapy in No...
FDA delays the review actions on two AbbVie supplemental NDAs for Rinvoq (upadacitinib), a JAK inhibitor for treating adults with active psoriatic art...