The Congressional Budget Office says several provisions in Sen. Alexanders Lower Health Care Costs Act would change FDA regulatory authority to speed ...
Two stakeholders suggest changes to an FDA draft guidance on medical device establishment inspection processes and standards.
Federal Register notice: FDA sends to OMB an information collection extension for its medical device user fee cover sheet.
Federal Register notice: FDA sends to OMB an information collection extension for its guidance on influenza A reagents.
Federal Register notice: FDA releases a draft guidance on drug regulatory submissions in electronic format.
FDA issues a draft guidance with current trial design recommendations and regulatory requirements for approving gonadotropin-releasing hormone analogu...
FDA approves Mercks Recarbrio (imipenem, cilastatin and relebactam), an antibacterial drug product to treat complicated urinary tract infections and c...
Federal Register notice: FDA seeks comments on an information collection extension for Product Jurisdiction: Assignment of Agency Component for Review...