The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug Products.” This draft guidance provides recommendations to applicants of approved new drug applications (NDAs) Read more

 The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning Read more

 The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act.” This draft guidance proposes select updates to the final guidance “Cybersecurity in Medical Devices: Quality Read more

 The Food and Drug Administration (FDA or Agency) has determined that Romidepsin Injection, 10 milligrams (mg)/2 milliliters (mL) (5 mg/mL) and 27.5 mg/5.5 mL (5 mg/mL), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated Read more

 The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DAURISMO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the Read more

 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports.” The draft guidance was prepared under the auspices of the Read more