Latest Federal Register Notices
Absorbable Perirectal Spacer Into Class 2
Federal Register notice: FDA classifies the absorbable perirectal spacer into Class 2 (special controls). 01/05/2018
Cervical Intraepithelial Neoplasia Tests Put Into Class 2
Federal Register notice: FDA classifies the cervical intraepithelial neoplasia (CIN) test system into Class 2 (special controls). 01/04/2018
Draft Guide on Certain Contraceptive Labeling
Federal Register notice: FDA makes available a draft guidance on “Labeling for Combined Hormonal Contraceptives.” 01/03/2018
Pediatric Advisory Committee Meeting in March
Federal Register notice: FDA announces a 3/23 Pediatric Advisory Committee meeting. 01/03/2018
Draft Guide on Hypogonadotropic Hypogonadism Drugs
Federal Register notice: FDA makes available a draft guidance entitled “Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Non-Structural Disorders.” 01/03/2018
Joint Advisory Committee to Review Pain Drug
Federal Register notice: FDA announces a joint Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee meeting 2/14. 01/03/2018
Priority Review Voucher Issued to Spark Therapeutics
Federal Register notice: FDA issues a priority review voucher to Spark Therapeutics for gaining BLA approval of Luxturna (voretigene neparvovec), an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. 01/03/2018