FDAnews.com – Regulatory Update

  • Over the past week, the FDA issued final guidance on conducting clinical trials during major disruptions due to disasters and public health emergencies. Draft guidances were issued on biosimilar and interchangeable biosimilar labeling, demonstrating evidence of effectiveness with one clinical investigation, considerations for prescription drug use-related software, assessing drug manufacturing facilities identified in pending applications and formal meetings between the FDA and pharmaceutical sponsors or applicants.
  • Over the past week, the FDA issued final guidance on IRB review of individual patient expanded access submissions, postmarketing requirements and commitments, the Breakthrough Devices Program and the medical device Voluntary Improvement Program. Draft guidances were also issued on clinical and non-clinical studies of weight loss medical devices.
  • Over the past week, the FDA issued final guidance on human factors engineering principles for combination products, treatment of nontuberculous mycobacterial pulmonary disease and supply chain standards. Draft guidances were issued on GDUFA post-warning letter meetings, modernizing the 510(k) pathway, biological evaluation of medical devices, and development of endogenous Cushing’s syndrome and peptide drug products.
  • Over the past week, the FDA issued guidance on its intention not to take action to enforce the requirements of DSCSA until Nov. 27, 2024, recommendations on system attributes necessary to enable secure tracing of products at the package level under DSCSA, formal dispute resolution on pharmaceutical GMP scientific and technical issues, and use of real-world data to support regulatory decision making.
  • Over the past week, the FDA issued a draft guidance on product-specific guidances, extended the comment period on a draft guidance for human cellular and gene therapy products, published a list of bulk drugs for which there is a clinical need under section 503B of the FD&C Act and notices of advisory committee meetings for oncologic drugs, endocrinologic and metabolic drugs and vaccines and related biological products. 
  • Over the past week, the FDA issued final guidance on informed consent and premarket notification for magnetic resonance devices and extended the comment period for a draft guidance on demonstrating bioequivalence for type A medicated articles containing certain active pharmaceutical ingredient(s).
  • Over the past week, the FDA issued final guidance on acceptable intake limits for nitrosamines and draft guidances on QTc information in human prescription drug and biological product labeling, classification categories for biosimilars, formal meetings for biosimilars and postmarketing approaches in clinical trials.
  • Over the past week, the FDA issued final guidance for waivers, exceptions, and exemptions from Section 582 of the FD&C Act, draft guidance for previously approved antiretrovirals for treatment of HIV, and modifications to the list of recognized consensus standards.
  • Over the past week, the FDA issued final guidance for deoxyribonucleic acid (DNA) reactive impurities in pharmaceuticals, assessing biosimilar user fees, hydrogen peroxide-based contact lens products and CDER’s program for the recognition of voluntary consensus standards guidance on medical device development tools. The FDA 2024 user fees were also announced.
  • Over the past week, the FDA issued a guidance on medical device development tools.
  • Over the past week, the FDA has issued draft guidances on inborn errors of metabolism, clinical trial postmarketing studies and human cellular and gene therapy products.
  • Over the past week, the FDA the FDA has requested comments on a Cardiovascular and Renal Drugs Advisory Committee meeting.
  • Over the past week, the FDA issued final guidances on direct-to-consumer promotional labeling and advertisements and treatment for chronic rhinosinusitis with nasal polyps. Draft guidances were issued on psychedelic drugs, orthopedic implants and wholesaling under section 503B.
  • Over the past week, the FDA issued final guidance on oncology drug products used with certain in vitro diagnostic tests and draft guidance on formal dispute resolution and administrative hearings procedures.
  • Over the past week, the FDA issued final guidance on content of premarket submissions for device software functions.
  • Over the past week, the FDA issued final guidances on nonclinical evaluation of the immunotoxic potential of pharmaceuticals, drug-drug interaction assessment for therapeutic proteins and cover letter attachments for controlled correspondence and draft guidances on interstitial cystitis/bladder pain syndrome and ICH E6(R3) guideline for good clinical practice.
  • Over the past week, the FDA issued a proposed rule on Medication Guides and draft guidance on developing drugs for preventive treatment of migraines.
  • Over the past week, the FDA issued a notice of Abbott’s withdrawal of Cylert NDA, draft guidance on generally accepted scientific knowledge and final guidance on covariates in randomized clinical trials.
  • Over the past week, the FDA issued notices of draft guidances on pediatric research, a final decision on withdrawal of Makena and a determination on Catapres products.
  • Over the past week, the FDA issued several documents, including a final guidance for testing drug components for diethylene glycol and ethylene glycol and the announcement of a discussion paper on AI.

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