Food and Drug Administration
Federal agency responsible for regulations under Food and Drug Administration.
101 regulationsRevocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and the European Community
The FDA is ending an agreement with the European Union that allowed them to accept each other's inspection reports for drug manufacturing and medical devices without doing their own inspections. This means the FDA will now need to conduct its own inspections of some drugs and devices that were previously approved based on European inspections, which could affect how quickly new medications and medical products reach American patients.
Revocation of Methods of Analysis Regulation
The FDA is removing outdated methods that were previously used to test and analyze food, drugs, and other products to ensure they are safe. This change allows the agency to rely on newer, more accurate testing techniques that better protect public health.
Listing of Color Additives Exempt From Certification; Spirulina Extract
The FDA is allowing spirulina extract, a natural blue-green food coloring made from algae, to be used in foods without requiring special government testing and approval. This makes it easier for food companies to use this natural ingredient as a food dye in products like beverages, candies, and other foods.
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address
This FDA regulation sets the rules for how new medicines for animals get approved, taken off the market, or transferred between companies. It matters to pet owners, farmers, and livestock producers because it ensures animal medications are safe and effective before being used.
Listing of Color Additives Exempt From Certification; Beetroot Red
The FDA is allowing beetroot red, a natural food coloring made from beetroots, to be used in foods without special certification testing. This makes it easier for food companies to use this natural red dye in products like candies, beverages, and baked goods.
Medical Devices; Neurological Devices; Classification of the Electrical Tongue Nerve Stimulator To Treat Motor Deficits
The FDA has officially classified a new medical device called an Electrical Tongue Nerve Stimulator that helps people recover movement after strokes or other injuries affecting motor control. This classification means the device can now be reviewed and approved for use by patients, establishing safety and effectiveness standards for this type of treatment.
Medical Devices; Quality Management System Regulation Technical Amendments
The FDA is making technical updates to the rules that medical device manufacturers must follow to ensure their products are safe and effective. These changes clarify and improve the existing quality control requirements that companies must meet before selling medical devices to patients.
Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products; Withdrawal
The FDA is withdrawing a proposed rule about testing methods to detect asbestos in talc-based cosmetic products like powders and makeup. This means the FDA is stepping back from requiring specific lab tests to check whether these products contain asbestos, a dangerous substance that can cause serious lung diseases.
Medical Devices; Neurological Devices; Classification of Field Generator Positioning Device
The FDA is officially classifying a medical device called a field generator positioning device, which is used to help position equipment during neurological treatments and procedures. This classification determines what safety and approval requirements the device must meet before it can be sold and used on patients.
Medical Devices; Gastroenterology-Urology Devices; Classification of the Anchored Esophageal Sheath
The FDA is officially classifying a new medical device called the Anchored Esophageal Sheath, which is used in gastroenterology and urology procedures. This classification determines how strictly the device will be regulated and what safety requirements manufacturers must meet before selling it to hospitals and patients.
Green Innovation GmbH; Filing of Food Additive Petition (Animal Use)
A company called Green Innovation GmbH has asked the FDA to approve a new food additive that would be used in animal feed or animal products. The FDA is now reviewing this request and accepting public comments before deciding whether to allow this additive for use in animals raised for food.
Immunology and Microbiology Devices; Reclassification of Nucleic Acid-Based Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product; Proposed Amendment; Proposed Order; Request for Comments
The FDA is proposing to change how it regulates genetic tests that help doctors match cancer patients with specific drugs designed to treat their particular tumors. This change could make it faster and easier for patients to access these personalized cancer treatments by streamlining the approval process for these tests.