An FDA town hall gives a detailed explanation of the new medical device Quality Management System Regulation and answers frequently asked questions about the new inspection process.
The Contraceptive Study Group submits a second petition to FDA seeking changes in labeling for hormonally active contraceptives to reflect all of the risks found in studies since the agents were introduced 50 years ago.
An FDA town hall gives a detailed explanation of the new medical device Quality Management System Regulation and answers frequently asked questions about the new inspection process.
The Contraceptive Study Group submits a second petition to FDA seeking changes in labeling for hormonally active contraceptives to reflect all of the risks found in studies since the agents were introduced 50 years ago.
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.
