🥗FDA Notification Procedures for Dietary Supplements
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.
Learn More🍔Notice on Ultra-Processed Foods from FDA and USDA
FDA and USDA (we) are requesting data and information to help develop a uniform definition of ultra-processed foods (UPF or UPFs) for human food products in the U.S. food supply. A uniform UPF definition, developed as part of a joint effort by federal agencies, would allow for consistency in research and policy to pave the way for addressing health concerns associated with the consumption of UPFs.
Learn More💊FDA Guidance on Formal Meetings for Biosimilar Products
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products." This guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of proposed biosimilar, including interchangeable biosimilar, products regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). This guidance finalizes the draft guidance of the same title issued on August 11, 2023.
Learn More👩⚕️Draft Guidance on Pregnant and Breastfeeding Women in Clinical Trials
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials." The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance is intended to provide general principles on the conduct of clinical trials that include pregnant and breastfeeding women to inform evidence-based decisions on safe and effective use of medicinal products by these populations. The draft guidance includes approaches to generating data that support informed decision-making on the safety, dosing, and efficacy of medicinal products during pregnancy and breastfeeding. Additionally, the draft guidance includes recommendations for recruiting and retaining pregnant and breastfeeding women in clinical trials, while reducing burden and harm on these participants.
Learn More💊FDA Issues Draft Guidance on Cancer Drug Combinations
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Development of Cancer Drugs for Use in Novel Combination--Determining the Contribution of the Individual Drugs' Effects." This draft guidance is intended for sponsors developing drugs for use in combination for the treatment of cancer and provides recommendations for characterizing the safety and effectiveness of individual drugs for use in a novel combination regimen in oncology (i.e., demonstrating the contribution of each drug to the overall effect that is observed for the population). This guidance expands on the recommendations in the 2013 guidance for industry entitled "Codevelopment of Two or More New Investigational Drugs for Use in Combination." This guidance does not address contribution of effect in settings where an investigational drug is being developed in combination with a drug approved for the same indication for the purposes of comparing the approved drug to the combination or to fixed combinations of previously approved drugs for the approved indication(s).
Learn More🍏FDA Revokes Obsolete Food Standards to Streamline Regulation
The Food and Drug Administration (FDA or we) revokes 11 food standards for foods that are no longer sold in the United States. FDA is taking this action as these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. This action will remove obsolete rules to reduce unnecessary regulatory requirements.
Learn More🍑FDA Proposes to Revoke Obsolete Food Standards Affecting Businesses
The Food and Drug Administration (FDA or we) is proposing to revoke 11 food standards for foods that are no longer sold in the United States. FDA is taking this action as we tentatively conclude these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. This action, if finalized, will remove obsolete rules to possibly reduce unnecessary regulatory requirements.
Learn More🧀FDA Proposes Revocation of Dairy Product Identity Standards
The Food and Drug Administration (FDA or we) is proposing to revoke 18 standards of identity for dairy products. FDA is taking this action as we tentatively conclude that these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. This proposed action would reduce redundant regulatory requirements.
Learn More🍏Proposed Rule to Revoke Food Standards
The Food and Drug Administration (FDA or we) is proposing to revoke 23 standards of identity for food. FDA is taking this action because we tentatively conclude that these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. This proposed action would reduce redundant regulatory requirements.
Learn More🩸FDA Guidance on Hepatitis B Testing for Blood Donations
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled "Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen; Draft Guidance for Industry." The draft guidance document provides blood establishments that collect blood and blood components, including Source Plasma, with FDA's recommendations for testing blood and blood components for hepatitis B surface antigen (HBsAg) to reduce the risk of transfusion-transmitted hepatitis B virus (HBV). The recommendations contained in the guidance apply to the collection of Whole Blood and blood components, including Source Plasma. The draft guidance, when finalized, is intended to supersede the recommendations regarding testing of all blood donations for HBsAg in the guidance document entitled "Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples From Donors of Whole Blood and Blood Components, Including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus" dated October 2012 (October 2012 Guidance). The guidance, when finalized, will also supersede information on the same topic that is in the document entitled "Recommendations for the Management of Donors and Units that are Initially Reactive for Hepatitis B Surface Antigen (HBsAg)" dated December 1987 (December 1987 Memorandum).
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