General GMP

The FDA CDER FOIA Electronic Reading Room page lists frequently requested or proactively posted compliance records for drugs. Its table identifies untitled letters and other correspondence by record date, FEI number where shown, firm, record type, country, and posting date. Listed firms include Neeyaan, Formulated Solutions, Port Jervis Laboratories, Chemspec Chemicals, Aptar Radolfzell, Amazon.com, Industria Farmaceutica Nova Argentia, Laurus Synthesis, Nectar Lifesciences, Shandong Boyuan Pharmaceutical, Silliker/Merieux NutriSciences, and Valisure. The page also directs users to FDA databases for inspections, drug-promotion untitled letters, Forms FDA 483, and establishment inspection reports. Content is marked current as of August 18, 2026.

FDA announced the availability of final industry guidance titled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers.” The question-and-answer guidance addresses commonly asked questions from applicants and other interested parties about postapproval manufacturing changes to biosimilar and interchangeable biosimilar products licensed under the Public Health Service Act. It finalizes the draft guidance with the same title issued on July 23, 2024. The guidance was issued by FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research under docket FDA-2024-D-2581. The source identifies it as Final Level 1 Guidance.

FDA reviewed DesBio/Deseret Biologicals’ website in July 2026 and determined that CHLA:10M was marketed as a drug for temporary relief of symptoms associated with chlamydia infection. FDA cited labeling claims concerning burning during urination, testicular tenderness or pain, vaginal discharge, and painful sexual intercourse. The agency stated that CHLA:10M was a new drug because it was not generally recognized as safe and effective for its labeled conditions of use, and no approved application was in effect for the product. FDA therefore concluded that its introduction or delivery for introduction into interstate commerce violated the FD&C Act. Although the labeling described CHLA:10M as homeopathic, FDA noted that its listed ingredient, Chlamydia trachomatis 10M, was not listed in the Homeopathic Pharmacopeia of the United States. FDA requested a written response describing corrective and preventive measures. The letter reports a website review and does not describe an inspection or identify manufacturing, laboratory, validation, contamination-control, data-integrity, facility, or other CGMP observations.

FDA’s Guidances | Drugs page explains that guidance documents reflect the Agency’s current thinking on particular subjects, do not create or confer rights, and do not bind FDA or the public. It states that alternative approaches may be used when they satisfy applicable statutory or regulatory requirements. The page directs users to FDA’s guidance search, including filtering by the Center for Drug Evaluation and Research and other criteria. It lists drug-related categories such as Chemistry, Manufacturing, and Controls, Current Good Manufacturing Practice, ICH-Quality, Microbiology, Pharmaceutical Quality, Compliance, and Electronic Submissions. It also links to withdrawn guidances, the CDER Guidance Agenda, product-specific guidances, Spanish translations, and good guidance practices resources.

FDA states that it will begin accepting requests on October 1, 2026, for year five of the Chemistry, Manufacturing, and Controls Development and Readiness Pilot. The program supports selected CBER- and CDER-regulated products under investigational new drug applications with accelerated clinical development timelines. Accepted sponsors may discuss CMC product development strategies and goals with FDA review staff during two predesignated Type B meetings, with follow-up discussions available for questions or clarification. FDA will select no more than nine proposals per year. Participation requests must be submitted as IND amendments with the specified cover-letter statement. The pilot will continue through fiscal year 2027.

What happened The FDA Compounding Quality Center of Excellence conducts the Compounding Outsourcing Facilities Annual Study to understand industry perspectives, challenges, and supplier-purchaser dynamics. Each study combines a survey, stakeholder discussions, and analysis of existing data; a research partner works under FDA direction, and survey and discussion data are anonymous to FDA. Published summaries describe … Read more