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Food and Drug Administration, HHS.
Notice of availability.
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 This guidance finalizes the draft guidance of the same title issued on September 22, 2023.
The announcement of the guidance is published in the Federal Register on September 12, 2025.
You may submit either electronic or written comments on Agency guidances at any time as follows:
Submit electronic comments in the following way:
Submit written/paper submissions as follows: ( printed page 44195)
Instructions: All submissions received must include the Docket No. FDA-2023-D-3031 for “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.
Jessica Dunn, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4214, Silver Spring, MD 20993-0002, 240-402-8985; or Phillip Kurs, Center for Biologics Evaluation and Research, Food and Drug Administration, 240-402-0467.
FDA is announcing the availability of a 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 an NDA, an ANDA, a BLA, or a supplement to any of these types of applications. As part of the negotiations relating to the reauthorization of BsUFA and PDUFA, 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 COVID-19 pandemic. This guidance, within the context of approval and licensure decisions by FDA, describes the use of alternative tools to assess manufacturing facilities identified in an NDA, an ANDA, or a BLA to establish that these facilities meet the applicable requirements, including under section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)) and either section 505 of the FD&C Act (21 U.S.C. 355) or section 351 of the Public Health Service Act (42 U.S.C. 262). FDA considered the applicability of Executive Order 14192, per OMB guidance in M-25-20, and finds this action to be deregulatory in nature.
During the pandemic, FDA expanded its use of alternative tools to evaluate drug manufacturing facilities to support regulatory decision making when facility inspections were not feasible. The following alternative tools were used during the COVID-19 public health emergency:
FDA has strategically used these tools within the context of decisions related to preapproval inspections (PAIs) or prelicense inspections (PLIs) to maximize facility assessment efficiency as part of appropriate, risk-based assessments. Given the success of these innovative approaches, FDA intends to continue risk-based use of these alternative tools and to apply certain virtual technological capabilities within a specific inspectional context defined within this guidance. When used in advance or in lieu of PAIs and PLIs or to support PAIs and PLIs, the appropriate use of these approaches will help FDA maintain operational flexibility to support timely facility evaluations and application decisions.
This guidance finalizes the draft guidance entitled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications” issued on September 22, 2023 (88 FR 65396). FDA considered comments received on the draft guidance as the guidance was finalized. Based on the comments received, FDA updated the guidance with additional clarification on: (1) the recommended timeframe for facilities to respond to section 704(a)(4) of the FD&C Act records requests; (2) the timeframes for when facilities may expect to receive requests from FDA to use a remote subject matter expert (SME) during an inspection; (3) Agency efforts to coordinate logistical approaches and technologies with facilities regarding FDA's use of alternative tools; and (4) the effect of a facility declining to allow FDA to use a remote SME or when a facility is unable to support the virtual interaction with a remote SME.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Alternative Tools: ( printed page 44196) Assessing Drug Manufacturing Facilities Identified in Pending Applications.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in 21 CFR parts 210 and 211 relating to current good manufacturing practice requirements and electronic records and signatures have been approved under OMB control numbers 0910-0139 and 0910-0303, respectively. The collections of information in 21 CFR part 314 relating to the submission of NDAs and ANDAs have been approved under OMB control number 0910-0001. The collections of information in 21 CFR part 601 relating to the submission of BLAs have been approved under OMB control number 0910-0338.
Persons with access to the internet may obtain the guidance at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https:/www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-17698 Filed 9-11-25; 8:45 am]
BILLING CODE 4164-01-P