FDA Drops Boring Guide to Surviving Drug Research Audits
Published Date: 12/19/2025
Notice
Summary
The FDA just released new guidance to help companies understand how bioresearch monitoring inspections work. If you run or work at research sites or labs, this guide explains what records to share, how to communicate with inspectors, and what to expect during inspections. These clear rules aim to make inspections smoother and more predictable, starting now, with no extra costs announced.
No Economic Impacts Identified for this Document
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-16959, Frequently Asked Questions-Developing Potential Cellular and Gene Therapy Products; Final Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Frequently asked Questions--Developing Potential Cellular and Gene Therapy Products." The guidance document provides industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) products. The FAQs represent common questions directed to the Agency and span multiple disciplines, including regulatory review; chemistry, manufacturing, and controls (CMC); pharmacology/toxicology; clinical; and clinical pharmacology. This guidance announced in this notice finalizes the draft guidance of the same title issued on November 19, 2024.
2026-16939, GNT USA, LLC.; Filing of Color Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by GNT USA, LLC., c/o Exponent, Inc., proposing that we amend our color additive regulations to provide for the safe use of safflower (Carthamus tinctorius L.) extract as a color additive in various foods at levels consistent with good manufacturing practices.
2026-16942, Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium DL- methionine chelate as a nutritional source of chromium in cattle feed. This action is in response to a food additive petition filed by Zinpro Corp.
Previous / Next Documents
Previous: 2025-23403, Mt. Rainier Railroad LLC-Acquisition and Change of Operator Exemption-City of Tacoma, Department of Public Works d/b/a Tacoma Rail Mountain Division, and City of Tacoma, Department of Public Utilities d/b/a Tacoma Rail
Mt. Rainier Railroad LLC is buying and taking over a 33.6-mile rail line in Washington from the City of Tacoma’s Tacoma Rail divisions. This means Mt. Rainier Railroad will become the new operator, replacing Tacoma Rail, starting as soon as January 4, 2026. The line hasn’t been used for over a year, so no shippers need to be notified, and the deal won’t bring big money changes or affect major rail carriers.
Next: 2025-23405, Federal-State Unemployment Compensation Program: Certifications for 2025 Under the Federal Unemployment Tax Act
The Department of Labor just confirmed that all states’ unemployment programs meet federal rules for 2025. This means employers who pay into state unemployment funds can keep getting tax credits on their federal unemployment taxes, saving them money. These certifications cover the full year ending October 31, 2025, so businesses can plan ahead with confidence.