FR: Food and Drug Administration

Potential New Indication for Testosterone Replacement Therapy

FDA announced it has reviewed published literature suggesting testosterone replacement therapy (TRT) may be safe and effective for treating low libido in men with decreased libido associated with idiopathic hypogonadism. The Agency encourages holders of approved TRT new drug applications to contact FDA by April 30, 2026, for information on submitting a supplemental NDA for this potential new indication.

Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators

FDA announced draft guidance providing a proposed compliance policy for respirators approved by CDC NIOSH under 42 CFR part 84, including surgical N95 respirators, PAPRs, reusable elastomeric respirators, and FFRs for general public use during public health emergencies. Once finalized, the guidance is intended to facilitate more efficient and effective use of resources consistent with least burdensome device policies.

Establishing Impurity Specifications for Antibiotics Draft Guidance

FDA announced availability of draft guidance titled 'Establishing Impurity Specifications for Antibiotics,' providing recommendations for establishing specifications for organic impurities in antibiotics manufactured by fermentation and semi-synthesis. The draft guidance applies to antibiotic drugs subject to approval under NDAs, ANDAs, and associated type II drug substance DMFs, as well as OTC monograph antibiotic drugs. Comments are due by June 22, 2026.

Authorization of Emergency Use for Four Animal Drugs for Treatment of New World Screwworm

FDA announced the issuance of four Emergency Use Authorizations (EUAs) for animal drugs to treat New World screwworm infestations in livestock and companion animals. Three EUAs were issued to Boehringer Ingelheim Animal Health USA for prevention and treatment in cattle, dogs, and cats. One EUA was issued to Health and Hygiene (Pty) Ltd. for use in cattle, horses, sheep, goats, deer, birds, and captive wild mammals. The EUAs were effective on February 5, February 18, and March 10, 2026, following an August 2025 HHS determination of significant public health emergency potential.

Radioactive Drug Research Committees Information Collection

The FDA is soliciting public comments on an extension of existing information collection requirements related to Radioactive Drug Research Committees under 21 CFR 361.1. Under the Paperwork Reduction Act, the Agency must publish notice and allow 60 days for public comment before submitting the collection to OMB for approval. Comments are being sought on whether the proposed collection of information is necessary for proper FDA functions.

Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed

The FDA is announcing an opportunity for public comment on a proposed extension of its generic clearance for qualitative data collection. The collection supports social and behavioral research for food, dietary supplements, cosmetics, and animal food and feed. Under the Paperwork Reduction Act, the Agency must publish a 60-day notice and allow public comment before submitting the collection to OMB. Comments are due by June 16, 2026.

Animal Drug User Fee Act; Public Meeting; Request for Comments

The FDA announced a virtual public meeting on the Animal Drug User Fee Act (ADUFA) reauthorization process. The meeting will be held May 27, 2026, from 2 p.m. to 4 p.m. Eastern Time. The docket will remain open for comments until December 1, 2027, with comments suggesting program changes due by July 1, 2026 for publication on the FDA website.

Animal Generic Drug User Fee Act Public Meeting Request for Comments

The FDA announced a virtual public meeting on May 27, 2026 (11 a.m. to 1 p.m. ET) to gather stakeholder input on the Animal Generic Drug User Fee Act (AGDUFA) reauthorization. The docket (FDA-2011-N-0655) will remain open for comments through December 1, 2027, with comments for website publication due by July 1, 2026. This notice solicits feedback from the generic animal drug industry on program improvements.

MNEXSPIKE COVID-19 Vaccine Rare Pediatric Disease Priority Review Voucher Approval Notice

FDA issued a Notice announcing approval of MNEXSPIKE, an mRNA COVID-19 vaccine, under the Rare Pediatric Disease Priority Review Voucher program. The voucher program incentivizes development of treatments for rare pediatric diseases by providing priority review vouchers that can be used for future FDA review requests. Docket No. FDA-2026-N-3447.

Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; MRESVIA (Respiratory Syncytial Virus Vaccine)

FDA announces approval of MRESVIA (Respiratory Syncytial Virus Vaccine) and issuance of a Rare Pediatric Disease Priority Review Voucher under the voucher program established by the FDA Modernization Act of 2012. The approval was granted under Docket No. FDA-2026-N-3466 and published in 91 FR 20471 on April 16, 2026. This notice documents the completion of the regulatory review and voucher issuance for the vaccine product targeting RSV in pediatric populations.

MRESVIA RSV Vaccine Approval Under Material Threat Medical Countermeasure Priority Review Voucher

FDA approved MRESVIA (Respiratory Syncytial Virus Vaccine) using a Material Threat Medical Countermeasure Priority Review Voucher. The approval was announced via Federal Register Notice (Docket No. FDA-2026-N-3500, 91 FR 20467) on April 16, 2026. This action grants market authorization for the RSV vaccine, which was reviewed under an expedited pathway designed to encourage development of medical countermeasures addressing material public health threats.

AREXVY RSV Vaccine Approved for Rare Pediatric Disease Priority Review Voucher

The FDA granted a Rare Pediatric Disease Priority Review Voucher to AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) under Docket No. FDA-2026-N-3446. The voucher, published at 91 FR 20460, was awarded upon approval of the vaccine product.AREAS XVY is manufactured by GSK and is indicated for active immunization against RSV disease in adults 60 years and older, and in infants through maternal immunization.

Pharmacy Compounding Advisory Committee Meeting and Bulk Drug Substances Public Comment Request

The FDA announces a Pharmacy Compounding Advisory Committee meeting scheduled for July 23-24, 2026, and establishes a public docket (FDA-2025-N-6895) to receive comments on bulk drug substances nominated for inclusion on the Section 503A Bulk Drug Substances List. The agency seeks input from stakeholders on whether these nominated substances should be approved for use in pharmacy compounding.

New Animal Drug Applications - Approval and Withdrawal Actions (Oct-Dec 2025)

FDA issued a final rule amending animal drug regulations to reflect application-related actions for NADAs, ANADAs, and CNADAs during October, November, and December 2025. The rule includes approval of original and supplemental applications, conditional approvals, sponsor changes, sponsor address changes, and withdrawal of approvals. Affected parties include sponsors and manufacturers of animal drug products. The rule is effective April 16, 2026.

REVIA Naltrexone 50mg Tablets Not Withdrawn for Safety Determination

FDA has determined that REVIA (naltrexone hydrochloride) tablets, 50mg, was not withdrawn from sale for reasons of safety or effectiveness. The drug, originally approved November 20, 1984, under NDA 018932 held by Teva Women's Health, Inc., was subject to a withdrawal request dated May 16, 2018. This determination permits FDA to continue approving abbreviated new drug applications (ANDAs) that refer to this listed drug product.

Determination That CHEWTADZY (Tadalafil) Chewable Tablets Were Not Withdrawn From Sale for Safety or Effectiveness

FDA determined that CHEWTADZY (tadalafil) chewable tablets, 5 mg, 10 mg, and 20 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination removes a statutory barrier and allows FDA to approve abbreviated new drug applications (ANDAs) for generic versions of the drug product if all other legal and regulatory requirements are met. The drug is subject of NDA 218527, held by B Better, LLC, which was initially approved on June 28, 2024.

Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs

The FDA is announcing an opportunity for public comment on a proposed information collection associated with orphan drug requirements under the Paperwork Reduction Act of 1995. The Agency seeks input on existing collection requirements related to orphan drug designation. Comments must be submitted by June 15, 2026.

FDA Determines Regulatory Review Period for UNLOXCYT Patent Extension

FDA Determines Regulatory Review Period for UNLOXCYT Patent Extension

Increasing Access to Nonprescription Drugs; Public Meeting; Request for Comments

The FDA announced a public meeting on April 23, 2026 to gather stakeholder perspectives on increasing access to nonprescription drugs. The meeting will be held virtually and in person at the National Press Club in Washington, DC. Written and electronic comments are due by May 8, 2026.

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.

Color Additive Certification Information Collection Comment Request

The FDA published a notice in the Federal Register announcing an opportunity for public comment on a proposed information collection related to color additive certification under the Paperwork Reduction Act. The notice solicits comments on the burden associated with color additive certification requirements. Comments must be submitted by June 9, 2026.

Petition Submission Information Collection: Food Additive, Color Additive, Master File, Form 3503

The FDA published a notice announcing a 60-day public comment period on proposed information collection requirements for petition submissions under the Paperwork Reduction Act. The collection covers food additive petitions, color additive petitions including labeling, master file information submissions, and electronic submissions using FDA Form 3503. Comments must be submitted by June 9, 2026.

GSK Withdraws Wellcovorin NDA - Leucovorin Calcium Tablets Discontinued

FDA withdrew approval of NDA 018342 for Wellcovorin (leucovorin calcium) tablets at GSK's written request after the company notified the Agency the drug products were no longer marketed. GSK waived its opportunity for a hearing and requested withdrawal under 21 CFR 314.150(c). Existing inventory may be dispensed until depleted or until expiration dates.

Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices

The FDA published a notice in the Federal Register seeking public comment on a proposed information collection related to premarket approval of medical devices. The collection pertains to burden hour estimates for required submissions under the Paperwork Reduction Act. Comments are due within 60 days of the April 10, 2026 publication date.

Determination of Regulatory Review Period for INJECTAFER Patent Extension

FDA has determined the regulatory review period for INJECTAFER (ferric carboxymaltose injection) and published this notice as required by law. The determination is needed for the USPTO to calculate patent term extension under the Hatch-Waxman Act. Comments on the calculation may be submitted by June 2, 2026; petitions regarding due diligence may be filed by September 30, 2026.

Customer Service Satisfaction Survey Collection

The FDA is seeking public comments on a proposed information collection for customer service satisfaction surveys. Under the Paperwork Reduction Act of 1995, federal agencies must publish notice and allow 60 days for public comment on proposed collections. Comments are due by June 2, 2026.

Determination of Regulatory Review Period for HYMPAVZI Patent Extension

The FDA has determined the regulatory review period for HYMPAVZI, a human biological product, and published this notice as required by law. The determination was made in connection with an application to the USPTO for extension of a patent claiming the product. Interested parties may submit comments or petitions regarding the determination.

Determination of Regulatory Review Period for Purposes of Patent Extension; EMRELIS

The FDA has determined the regulatory review period for EMRELIS, a human biological product, and published this notice as required by law for patent extension purposes. The determination affects the calculation of patent term extension under federal law. Comments on the determination may be submitted until June 2, 2026, and petitions regarding due diligence may be filed until September 30, 2026.

Determination of Regulatory Review Period for Patent Extension; ENFLONSIA

The FDA has determined the regulatory review period for ENFLONSIA, a human biological product, and published this notice as required by 21 CFR Part 60. The notice allows any person to submit comments correcting dates by June 2, 2026, and any interested party may petition FDA by September 30, 2026 regarding due diligence during the review period.

Determination of Regulatory Review Period for VYLOY Patent Extension

The FDA has determined the regulatory review period for VYLOY, a human biological product, for patent extension purposes. The Agency is publishing this notice as required by law due to patent extension applications submitted to the USPTO. Comments regarding date corrections must be submitted by June 2, 2026, and petitions for due diligence determinations may be filed by September 30, 2026.

Determination of Regulatory Review Period for ENCELTO Patent Extension

The FDA has determined the regulatory review period for ENCELTO, a human biological product, and published this notice as required by law for patent extension purposes under 35 U.S.C. 156. The determination opens a public comment period through June 2, 2026, and allows petitions regarding due diligence through September 30, 2026.

ZIIHERA Regulatory Review Period Determination for Patent Extension

The FDA has determined the regulatory review period for ZIIHERA, a human biological product, and is publishing this notice as required by law for patent extension purposes under 21 USC 356. The determination is being forwarded to the USPTO for use in processing the patent extension application. Interested parties may submit comments on the accuracy of published dates or petition FDA regarding due diligence during the review period.

Priority Review Voucher Issuance; KRESLADI Rare Pediatric Disease Product

FDA announced the issuance of a priority review voucher to Rocket Pharmaceuticals, Inc. for KRESLADI (marnetegragene autotemcel), approved March 26, 2026, for treatment of pediatric patients with severe leukocyte adhesion deficiency-I (LAD-I). The voucher was awarded under section 529 of the FD&C Act's Rare Pediatric Disease Priority Review Voucher Program. This notice fulfills FDA's statutory requirement to publish voucher awards.

FDA Guidance on Incorporating Patient Preference Information

The Food and Drug Administration (FDA) has issued a notice announcing the availability of its final guidance on incorporating voluntary patient preference information throughout the total product life cycle. This guidance is intended for industry, FDA staff, and other interested parties.

FDA Correction: Withdrawal of 72 ANDAs - Upsher-Smith Laboratories

The FDA issued a correction to a notice that incorrectly announced the withdrawal of approval for Upsher-Smith Laboratories' abbreviated new drug application (ANDA) 070631 for valproic acid capsules. The company had timely requested that the approval not be withdrawn, and this correction reinstates its validity.

FDA Reclassifies Melanoma Detection and Impedance Devices

The FDA has reclassified certain optical diagnostic devices for melanoma detection and electrical impedance spectrometers. These devices will now be renamed Software-Aided Adjunctive Diagnostic Devices for Use on Skin Lesions by Physicians Trained in the Diagnosis and Management of Skin Cancer. This reclassification aims to better categorize these diagnostic tools.

Spirulina Extract Color Additive Effective Date Delayed

The FDA has delayed the effective date of its final order regarding spirulina extract as a color additive. The original effective date of February 6, 2026, is now indefinitely postponed, with a new effective date to be announced via a future Federal Register publication.

FDA Delays Effective Date for Beetroot Red Color Additive

The Food and Drug Administration (FDA) has delayed the effective date for the final order concerning the color additive Beetroot Red. The original effective date of February 6, 2026, is now indefinitely postponed, with the FDA to announce a new effective date or further administrative action via a future Federal Register notice.

FDA Seeks Comment on Advisory Committee Information Collection

The Food and Drug Administration (FDA) is requesting public comment on its proposed collection of information related to advisory committee activities. This notice initiates a comment period for stakeholders to provide feedback on the agency's information collection requests concerning these committees.

FDA Proposed Collection for Animal Drug User Fees

The Food and Drug Administration (FDA) has published a proposed collection of information regarding animal drug and animal generic drug user fees. This notice initiates a public comment period for the proposed reporting requirements associated with these user fees.

FDA National Priority Voucher Pilot Program Public Hearing Request

The FDA is announcing a public hearing regarding its National Priority Voucher Pilot Program. The hearing will be held on June 12, 2026, and is intended to gather public input on the program. Registration details and requests for participation are available on the FDA website.

FDA Draft Guidance on New Approach Methodologies in Drug Development

The FDA has issued draft guidance for industry on the use of New Approach Methodologies (NAMs) in drug development. This guidance provides recommendations for sponsors on how to incorporate NAMs into their regulatory submissions. The comment period for this draft guidance closes on May 18, 2026.

FDA Proposed Collection of Information on Premarket Notifications

The FDA has proposed a new collection of information regarding premarket notifications. This is a request for comments on the proposed collection, with a deadline of May 18, 2026.

FDA Advisory Committee Renewal: Obstetrics, Reproductive and Urologic Drugs

The Food and Drug Administration (FDA) has announced the renewal of the Obstetrics, Reproductive and Urologic Drugs Advisory Committee for an additional two years. The committee's charter will now be in effect until March 23, 2028, continuing its role in advising on drug safety and effectiveness.

FDA Determination: Methergine Injection Not Withdrawn for Safety or Effectiveness

The FDA has determined that Methergine (methylergonovine maleate) injection was not withdrawn from sale for safety or effectiveness reasons. This determination allows the FDA to approve abbreviated new drug applications (ANDAs) for generic versions of this product, provided other requirements are met.

FDA Notice: Preparation for Cosmetics Regulation Meeting and Request for Comments

The FDA is requesting public comments to prepare for the twentieth International Cooperation on Cosmetics Regulation (ICCR-20) annual meeting. The input will help inform the agency's participation in discussions on cosmetics regulation. Comments are due by May 18, 2026.

OTC Monograph Drug Facility Fee Rates for FY 2026

The FDA has published the Over-the-Counter (OTC) Monograph Drug Facility (MDF) fee rates for fiscal year 2026. These fees are authorized by the Over-the-Counter Monograph Drug User Fee Amendments (OMUFA II) and support FDA's OTC monograph drug activities.

FDA Guidance on Topical Drug Product Characterization for ANDAs

The FDA has issued a final guidance document for industry on the physicochemical and structural characterization of topical drug products submitted in abbreviated new drug applications (ANDAs). This guidance provides recommendations to assist applicants in identifying dosage forms and describing critical performance properties to support bioequivalence demonstrations for generic topical products.

FDA: Gluten Labeling and Cross-Contact Comment Period Extension

The Food and Drug Administration (FDA) has extended the public comment period for its request for information regarding gluten labeling and preventing cross-contact in packaged foods. The original notice was published on January 22, 2026, and the comment period is now extended to April 22, 2026.