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Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry

FDA announced availability of draft guidance providing recommendations for next-generation sequencing (NGS)-based methods used in nonclinical studies to support initiation of clinical trials of investigational human genome editing products. The draft guidance is open for public comment until July 14, 2026 (90-day comment period). Comments should be submitted to Docket No. FDA-2026-D-1255.

Financial Transparency and Efficiency of PDUFA, BsUFA, and GDUFA; Public Meeting

The FDA is announcing a public meeting on June 23, 2026, to discuss financial transparency and efficiency of the Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BsUFA), and Generic Drug User Fee Amendments (GDUFA). The hybrid meeting will be held at FDA White Oak Campus and via Microsoft Teams. Written and electronic comments on the meeting topic must be submitted by July 23, 2026.

Interoperability Standards for Prior Authorization APIs for Medicare Advantage, Medicaid, CHIP, and QHP Issuers

CMS proposes requiring Medicare Advantage organizations, Medicaid FFS programs, CHIP FFS programs, Medicaid managed care plans, CHIP managed care entities, and QHP issuers on FFEs to implement electronic prior authorization APIs for drugs. The rule would extend existing interoperability requirements to cover drug prior authorizations, adopt HL7 FHIR standards as HIPAA-covered transaction standards, require API endpoint reporting to CMS, and add a definition of failure to report for civil monetary penalty purposes.

Acknowledgment Letter to Mom3nts Production

FDA's Center for Devices and Radiological Health (CDRH), Division of Manufacturers and Communication (DMB), issued an acknowledgment letter to Mom3nts Production. The letter confirms receipt of a submission filed under docket FDA-2025-V-3791. No documents are available for public viewing on Regulations.gov; the letter content is contained in an attachment.

FDA Center for Tobacco Products Complaint Submission

The FDA Center for Tobacco Products received a complaint document under docket FDA-2026-H-3868. The comment period has closed and no documents are available for public viewing. The nature and content of the complaint are not accessible through the regulatory filing system.

FDA Center for Tobacco Products Files Complaint - April 2026

The FDA Center for Tobacco Products (CTP) filed a complaint on April 14, 2026, initiating a formal enforcement action against tobacco product manufacturers. The complaint was submitted to regulations.gov under docket FDA-2026-H-3832. This filing represents FDA's regulatory enforcement mechanism for addressing violations of tobacco product standards under the Family Smoking Prevention and Tobacco Control Act.

Complaint Filed by Center for Tobacco Products

The FDA Center for Tobacco Products (CTP) filed a complaint with tracking number FDA-2026-H-3841. The complaint was submitted on April 14 and is now accessible via regulations.gov. Only a PDF attachment of the complaint is available for download; no summary documents are viewable on the regulatory portal.

B.E. Meyers & Co. Variance Application - CDRH

B.E. Meyers & Co., Inc. has submitted a variance application to the FDA Center for Devices and Radiological Health (CDRH). The application requests permission to deviate from specific regulatory requirements applicable to the company's medical device operations. FDA has received and posted the application for public access via Regulations.gov under docket FDA-2025-V-4733-0001.

FDA Center for Tobacco Products Complaint Regarding Retailer Violation

The FDA Center for Tobacco Products (CTP) filed a complaint (FDA-2026-H-3866-0001) on April 14. The complaint relates to potential violations of federal tobacco product regulations, specifically concerning retailer compliance with sales and marketing requirements. The document represents a formal complaint filing within the FDA's regulatory enforcement process.

Variance Amendment - SRS Visual, CDRH

FDA's Center for Devices and Radiological Health (CDRH) issued a variance amendment related to SRS Visual. The variance was filed under docket FDA-2026-V-2145. The specific regulatory requirements being modified and the scope of the variance cannot be determined from available metadata as the full document content is not accessible.