Healthcare

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.

FDA Variance Application from J.M.W. Entertainment Group

The FDA has posted a variance application from The J.M.W. Entertainment Group, LLC. This document is available for review on the Regs.gov platform. No further details on the nature of the variance or its implications are provided in the notice.

FDA Acknowledgment Letter to Audio Source, Inc

The FDA has issued an acknowledgment letter to Audio Source, Inc. regarding a submission. This notice confirms receipt of the document by the agency.

FDA Complaint Document Details

The FDA has posted details regarding a complaint document, with the information made available on March 16, 2026. The document is related to a complaint filed with the agency.

FDA Document on Contraceptive Status Among Females 15-49

The Food and Drug Administration (FDA) has issued a document concerning contraceptive status among females aged 15-49. This notice provides information on the topic without introducing new regulatory requirements.

FDA Background Material on Contraceptive Use and HIV-1 Transmission Risk

The FDA has posted background material concerning contraceptive use and the risk of HIV-1 transmission. This notice provides scientific information relevant to public health discussions and regulatory considerations.

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.

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.