🧫FDA Reclassifies Hepatitis B Assays, Easing Market Entry
The Food and Drug Administration (FDA) is issuing a final order reclassifying qualitative hepatitis B virus (HBV) antigen assays (product code LOM), HBV antibody assays (product code LOM), and quantitative HBV nucleic acid-based assays (product code MKT), all of which are postamendments class III devices, into class II (special controls), subject to premarket notification. FDA is also establishing the special controls that are necessary to provide a reasonable assurance of safety and effectiveness of these device types.
Learn More💊FDA Draft Guidance on Coccidioidomycosis Drug Development Available
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Disseminated Coccidioidomycosis: Developing Drugs for Treatment." The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of disseminated coccidioidomycosis caused by Coccidioides species (i.e., C. immitis and C. posadasii).
Learn More💊FDA Draft Guidance for sGERD Drug Development
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment." The draft guidance details FDA's recommendations on the clinical trials for drugs being developed for the treatment of symptomatic nonerosive gastroesophageal reflux disease (sGERD) in adults, including considerations for eligibility criteria, trial design features, efficacy evaluations, and safety assessments.
Learn More🥪FDA Proposes Removal of Orange B Color Additive Regulation
The Food and Drug Administration (FDA or we) is proposing to issue an order that would remove the color additive regulation that allows for the use of Orange B for coloring the casings or surfaces of frankfurters and sausages. Based on certification data, it appears that Orange B is no longer used for coloring the casings or surfaces of frankfurters and sausages and has not been certified for use as a color additive in food marketed in the United States since 1978. Because the authorized use of Orange B appears to have been abandoned, we have tentatively concluded that this color additive regulation is outdated and unnecessary.
Learn More💊FDA Issues Draft Guidance for Developing Drugs for Erosive Esophagitis
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Erosive Esophagitis: Developing Drugs for Treatment." The draft guidance details recommendations on clinical trials for drugs being developed for the healing of erosive esophagitis (EE) and maintenance of healed EE in adults, including considerations for eligibility criteria, trial design features, efficacy evaluations, and safety assessments.
Learn More🏭FDA Guidance on Alternative Tools for Drug Manufacturing Assessment
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications." This guidance provides information to applicants on how FDA intends to use alternative tools to assess drug manufacturing facilities identified in a marketing application (i.e., a new drug application (NDA), an abbreviated new drug application (ANDA), a biologics license application (BLA), or a supplement to any of these types of applications). As part of the negotiations relating to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA), as described in "PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027" (PDUFA VII commitment letter) and "Biosimilar Biological Product Reauthorization Performance Goals and Procedures for Fiscal Years 2023 Through 2027" (BsUFA III commitment letter), FDA agreed to issue guidance on the use of alternative tools to assess manufacturing facilities named in pending applications and to incorporate best practices from the use of such tools during the Coronavirus Disease 2019 (COVID-19) pandemic. This guidance finalizes the draft guidance of the same title issued on September 22, 2023.
Learn More💊Drug Enforcement Administration Notice on Fresenius Kabi Application
Fresenius Kabi USA, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
Learn More🧠FDA Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Digital Health Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA. The meeting will be open to the public. FDA is establishing a docket for public comment.
Learn More💊FDA Releases Guidance on Non-Opioid Analgesics for Chronic Pain
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Development of Non-Opioid Analgesics for Chronic Pain." This guidance is intended to assist sponsors in the development of non- opioid analgesics for the treatment of chronic pain. It describes FDA's current recommendations regarding phase 3 trials for prescription non- opioid analgesic products being developed to treat chronic pain. This guidance also responds to the statutory requirements of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act, which directs FDA to issue or update existing guidance to help address challenges to developing non- opioid medical products to treat pain.
Learn More📋FDA Guidance on Biosimilar Classification Categories Released
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Classification Categories for Certain Supplements Under BsUFA III." This guidance provides recommendations for applicants on classification categories A, B, C, D, E, and F for original and resubmitted prior approval supplements submitted to approved applications for biosimilar and interchangeable biosimilar products under the Public Health Service Act (PHS Act). The commitment letter associated with the Biosimilar User Fee Amendments of 2022 (BsUFA III) sets forth these supplement classification categories and their associated review performance goals. This guidance is intended to help applicants identify the appropriate classification category and review goal date of the supplement being submitted. This guidance finalizes and replaces the draft guidance of the same title issued on August 11, 2023.
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