Federal Register notice: FDA announces a 4/14 public meeting entitled International Cooperation on Cosmetics Regulation (ICCR) Preparation for ICCR14...
Federal Register notice: FDA makes available 43 product-specific guidances for generic drug developers.
Federal Register notice: FDA makes available a final guidance entitled Bone Anchors Premarket Notification (510(k)) Submissions.
FDA warns Market America about violations in its distribution of contract-manufactured dietary supplements.
FDA posts a draft guidance on Soft (Hydrophilic) Daily Wear Contact Lenses Performance Criteria for Safety and Performance Based Pathway.
Two companies ask FDA to clarify technical aspects of a draft guidance on the development of transdermal and topical delivery systems.
FDA warns Italys Silfradent about QS and MDR violations in its manufacturing of the Surgybone medical device.
KemPharm files a 505(b)(2) for serdexmethylphenidate, indicated for treating attention deficit hyperactivity disorder.