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FDA Complaint Posted for Public Comment

The FDA has posted a complaint for public comment, with the comment period closing on March 16, 2026. This action allows for public input on a specific complaint filed with the agency.

Hormonal Contraceptive Eligibility for Women at High HIV Risk

The FDA has issued draft guidance regarding the eligibility of hormonal contraceptives for women at high risk of HIV. This guidance aims to clarify recommendations and ensure appropriate access to contraceptive methods while considering HIV prevention strategies.

FDA Progestins Classification and Pharmacology

The Food and Drug Administration (FDA) has published a document detailing the classification and pharmacology of progestins. This guidance provides information for manufacturers and pharmaceutical companies regarding these substances.

FDA Glucocorticoid Receptor Gene Expression Study

The FDA has posted a study concerning Glucocorticoid Receptor gene expression. This notice is for informational purposes and does not introduce new regulatory requirements.

FDA Study on Contraceptives, Herpes, and HIV Risk

The FDA has posted a study concerning the relationship between contraceptives, herpes, and HIV risk. The study details are available through the agency's regulatory portal.

FDA Study on Oral Contraception and HIV Risk in Africa

The FDA has published a notice regarding a study on the relationship between oral contraception and HIV risk in Africa. This notice is associated with docket number FDA-2026-P-2641-0031.

FDA Guidance on Progestins as Endocrine Disruptors

The FDA has issued new guidance concerning progestins and their potential role as endocrine disruptors. This document outlines the agency's current thinking and provides information relevant to manufacturers and public health authorities.

HHS OIG Audit of Gateway Health Plan Medicare Advantage Compliance

The HHS Office of Inspector General (OIG) audited Gateway Health Plan, Inc.'s submission of diagnosis codes to CMS for Medicare Advantage risk adjustment. The audit found that most sampled diagnosis codes were not supported by medical records, leading to an estimated $4.3 million in net overpayments for 2018 and 2019.

FDA Variance Approval for North Bay Productions

The FDA has issued a variance approval letter to North Bay Productions. This document, originating from the CDRH, signifies an approval related to a specific variance request.

FDA Mammography Standards Quality Act Requirements Comment Request

The FDA has submitted a proposed collection of information related to Mammography Quality Standards Act requirements to the Office of Management and Budget (OMB) for review. The agency is requesting public comments on this information collection, with a deadline of April 13, 2026.