The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. ​Federal Register Documents from Food and Drug Administration Read more

 The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.” The guidance focuses on frequently asked questions about the new dietary ingredient notification submission 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 the Agency) is announcing the availability of the decision to deny a request for a hearing regarding the proposal of the Center for Drug Evaluation and Research (CDER) to refuse to approve the supplemental new drug application (sNDA) Read more

 The Food and Drug Administration (FDA or Agency) is amending the standing advisory committee regulations to add the establishment of the Genetic Metabolic Diseases Advisory Committee (GeMDAC or the Committee) to the list of standing committees. ​Federal Register Documents from Food and Drug Administration Read more

 The Food and Drug Administration (FDA or Agency) is announcing the availability of final guidances for industry entitled “Q2(R2) Validation of Analytical Procedures” and “Q14 Analytical Procedure Development.” The guidances were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Read more