An FDA town hall gives a detailed explanation of the new medical device Quality Management System Regulation and answers frequently asked questions ab...
The Contraceptive Study Group submits a second petition to FDA seeking changes in labeling for hormonally active contraceptives to reflect all of the ...
CDER issues two revised Manuals of Policies and Procedures relating to developing and communicating postmarketing requirements and commitments.
FDA cites significant manufacturing and data integrity deficiencies at Hikal Limited following a 2/2025 inspection of the companys active pharmaceutic...
FDA approves Travere Therapeutics Filspari (sparsentan), a therapy for treating patients with Focal Segmental Glomerulosclerosis.
FDA publishes a guidance titled "Bioanalytical Method Validation for Biomarkers to help sponsors to validate bioanalytical methods used to evaluate bi...
FDA warns Philadelphia, PA-based Medical Products Laboratories about CGMP violations in its manufacturing of unapproved new drugs.
FDA warns Livonia, MI-based Purolea Cosmetics Lab about CGMP and other violations in its production of finished drugs as a contractor.
