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CMS Seeks Public Comment on Information Collection Proposals

The Centers for Medicare & Medicaid Services (CMS) is seeking public comment on its intention to collect information from the public, as required by the Paperwork Reduction Act. This notice provides an opportunity for stakeholders to comment on proposed information collections, including revisions to existing ones.

CMS Seeks Public Comment on Information Collection Activities

The Centers for Medicare & Medicaid Services (CMS) is seeking public comment on its intention to collect information, specifically regarding the State-based Exchange Annual Reporting Tool (SMART). This notice is part of the Paperwork Reduction Act process, allowing for public input on the necessity and utility of the proposed information collection.

CMS Seeks Public Comment on Information Collection Activities

The Centers for Medicare & Medicaid Services (CMS) is requesting public comment on its intention to collect information from the public, as required by the Paperwork Reduction Act. This notice provides an opportunity for comment on the necessity, utility, and burden of proposed information collections.

CMS Agency Information Collection Activities Proposed for Public Comment

The Centers for Medicare & Medicaid Services (CMS) is seeking public comment on proposed information collections under the Paperwork Reduction Act. The comment period is open for 60 days, closing on May 18, 2026.

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.

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FDA Determination: Methergine Injection Not Withdrawn for Safety or Effectiveness

The FDA has determined that Methergine (methylergonovine maleate) injection was not withdrawn from sale for safety or effectiveness reasons.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: 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.

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.

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.