FDA regulations

FDA draft guidance establishes impurity specifications for fermentation and semi-synthesis antibiotics in NDAs, ANDAs, and OTC monograph drugs to ensure consistent quality standards.

FDA invites approved testosterone replacement therapy drug manufacturers to pursue supplemental applications for treating low libido in men with idiopathic hypogonadism based on published literature review.

FDA issues draft guidance on compliance policies for NIOSH-approved air-purifying respirators including N95s, PAPRs, and reusable respirators to streamline premarket requirements and reduce regulatory burden.

Revival Animal Health recalls Breeder's Edge Foster Care and Shelter's Choice canine milk replacers due to variable vitamin D levels that may be elevated or insufficient in some batches.

Silver Moon LP's Loard's Ice Cream recalls all retail-sized products sold without ingredient labels due to undeclared allergens including milk, eggs, tree nuts, peanuts, soy, wheat, sulfites, and food color additives.

FDA holds a virtual public meeting to solicit comments on the Animal Drug User Fee Act program and considerations for its next reauthorization.

FDA is accepting public comments for 60 days on a proposed information collection for qualitative social and behavioral research data submissions related to food, dietary supplements, cosmetics, and animal feed.

The FDA will hold a public meeting to solicit comments on the Animal Generic Drug User Fee Act program and recommendations for its next reauthorization.

FDA seeks 60-day public comment on proposed information collection requirements for Radioactive Drug Research Committees governing radioactive drug use in basic research under the Paperwork Reduction Act.

FDA issues four Emergency Use Authorizations for animal drugs to prevent and treat New World screwworm infestations in cattle, dogs, cats, horses, and other species following HHS's August 18, 2025 public health emergency declaration.

The FDA seeks public comment on information collection requirements for orphan drugs; the 60-day comment period begins with this Federal Register notice.

FDA determines CHEWTADZY (tadalafil) chewable tablets were not withdrawn for safety or effectiveness reasons, enabling generic ANDA approvals for 5mg, 10mg, and 20mg formulations.

FDA approves MRESVIA respiratory syncytial virus vaccine under a rare pediatric disease priority review voucher program on June 12, 2025.

FDA approves MRESVIA (Respiratory Syncytial Virus Vaccine) on May 31, 2024, redeeming a material threat medical countermeasure priority review voucher under the FD&C Act.

FDA's Pharmacy Compounding Advisory Committee will hold a public meeting to advise on bulk drug substances for inclusion in the Section 503A list, with a public docket open for comments.