Federal Register notice: FDA releases a draft guidance on drug regulatory submissions in electronic format.
FDA issues a draft guidance with current trial design recommendations and regulatory requirements for approving gonadotropin-releasing hormone analogu...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...
Four stakeholders provide requested feedback to FDA on dietary supplement innovation.
Teleflex recalls its Neonatal ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column due to complaints about cracks in the device.
FDA clears an Integrated Endoscopy 510(k) for Nuvis Single-Use Arthroscope.
FDA warns Indias Stride Pharma about CGMP violations in its production of finished drugs.