FDA Policy/General
Federal Register notice: FDA has determined that Merck Sharp & Dohme’s Noxafil (posaconazole) 100g delayed-release tablets were not withdrawn from sale due to safety or effectiveness reasons. The determination means that the agency will continue to approve ANDAs that reference the product as long as they meet all
FDA Policy/General
Federal Register notice: FDA is announcing that it issued IntraBio a priority review voucher after determining its recent approval of Aqneursa (levacetylleucine), indicated for treating Niemann-Pick disease Type C in adults and pediatric patients, met the voucher criteria for issuance. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Endosseous Dental Implants and Endosseous Dental Implant Abutments — Performance Criteria for Safety and Performance Based Pathway.” Under the guidance, a sponsor of an endosseous implant and endosseous implant abutment device could satisfy agency requirements to compare a new device
FDA Policy/General
Federal Register notice: FDA is announcing that it approved on 9/17 a product application that redeemed a priority review voucher —Novartis’ Kisqali (ribociclib) for combination use with an aromatase inhibitor for the adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative Stage II
FDA Policy/General
Federal Register notice: FDA is correcting a 2/2 final rule on device GMP requirements under the Quality System regulation. It erroneously omitted the definition of “batch” or “lot” that is now being added as follows: “Batch or lot means one or more components or finished devices that consist of
FDA Policy/General
Federal Register notice: FDA is announcing the Web site location where it is posting two lists of guidance documents that CDRH intends to publish in fiscal year 2025. In addition, the agency has established a docket where interested parties may comment on guidance priority topics, propose draft language for those
FDA Policy/General
Federal Register notice: FDA is announcing the revocation of an emergency use authorization issued to Janssen Biotech for the Janssen Covid-19 vaccine. The company notified the agency that the vaccine will not be marketed and requested that the authorization be revoked. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is announcing that it approved a product submission that redeemed a priority review voucher — Johnson & Johnson’s supplemental BLA for Tremfya (guselkumab) for treating adults with moderately to severely active ulcerative colitis. The agency is required to publish a notice when a priority review voucher
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers.” The document provides information and recommendations about the use of electronic systems, electronic records, and electronic signatures in clinical investigations of foods, medical products, tobacco products,
FDA Policy/General
Federal Register notice: FDA has determined that U.S. Antibiotics’ Augmentin XR (amoxicillin; clavulanate potassium) extended-release tablet, 1g; equivalent to 62.5mg base, was not withdrawn from sale for safety or effectiveness reasons. The determination will permit the agency to approve ANDAs that reference the product if all other
FDA Policy/General
Federal Register notice: FDA is announcing an 11/21 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to review an AstraZeneca supplemental BLA for Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo). The submission is seeking approval for the biologic’s use in patients treated with rivaroxaban or apixaban when reversal
FDA Policy/General
Federal Register notice: FDA is announcing a 10/31 Endocrinologic and Metabolic Drugs Advisory Committee meeting that will review a Lexicon Pharmaceuticals NDA for sotagliflozin oral tablets. The submission is seeking approval for the drug’s use as an adjunct to insulin therapy for improving glycemic control in adults with
FDA Policy/General
Today (10/1) marks the beginning of a new model for FDA inspections as part of a reorganization that was brought on by the 2022 infant formula debacle (see FDA Webview 1/2023 and 4/2022) FDA’s Office of Regulatory Affairs has been renamed the Office of Inspections and
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) plans to study the promotion of prescription drugs in a talk show format. A Federal Register notice says the research will look at advertising features through what is known as “native advertising,” a form of advertisement where marketers present paid content in
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Electronic User Fee Payment Request Forms — Form FDA 3913 and Form FDA 3914.” Form FDA 3913 was crafted to provide the minimum necessary information for FDA to review and process a user fee payment refund. Form FDA
FDA Policy/General
Federal Register notice: FDA is making available four final device-specific guidance documents for the Safety and Performance Based Pathway. They address performance criteria of air-powered dental handpieces and air motors, dental ceramics, dental impression materials, and dental cements. Under the pathway, a new device could come to market
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment.” The document provides clarification on recordkeeping, reporting, manufacturing, importing, and installation for an FDA-regulated electronic product. To view the notice, click here.
FDA Policy/General
FDA is outlining areas it feels can be optimized to help improve the advice received from advisory committee meetings. Writing in the 9/30 journal Nature, FDA commissioner Robert Califf and other top officials say they plan to refine the areas through future public engagements. One of the top focus
FDA Policy/General
Federal Register notice: FDA is seeking consumer organizations interested in participating in the selection process for voting or nonvoting consumer representatives to serve on its advisory committees or panels. Interested parties are encouraged to notify the agency in writing. FDA is also requesting nominations for voting or nonvoting consumer representatives
FDA Policy/General
Federal Register notice: FDA is announcing four information collections that have been approved by OMB. They are: * Biological Products; General Records and Postmarket Adverse Experience Reporting * Voluntary Total Product Life Cycle Advisory Program Pilot * New Plant Varieties Intended for Food Use * Food and Cosmetic Export Certificates To view the notice,
FDA Policy/General
Federal Register notice: FDA is proposing to reclassify qualitative hepatitis B virus (HBV) antigen assays, qualitative and quantitative HBV antibody assays, and quantitative HBV nucleic acid-based assays from Class 3 to Class 2 (general and special controls), subject to premarket notification. The agency is also proposing three new device
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for SpringWorks Therapeutics’ Ogsiveo (nirogacestat hydrobromide), indicated for adult patients with progressing desmoid tumors who require systemic treatment. The regulatory review period is 5,425 days, of which 5,089 days occurred during the testing phase