Author name: druganddevicedigest

FDA BRIEF: Week of October 3, 2016 ILARIS (canakinumab) injection Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA INDICATIONS: Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) ILARIS is indicated for the treatment of Tumor Necrosis Factor (TNF) receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients. Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) ILARIS …

FDA Approval, Classification: ILARIS, EPIC CLEARVIEW – Drug and Device Digest Read More »

FDA BRIEF: Week of  June 6, 2016 VAXCHORA (Cholera Vaccine, Live, Oral) Suspension for Oral Administration PaxVax Bermuda Ltd., Hamilton, BERMUDA. INDICATION:  Active immunization against disease caused by Vibrio cholerae serogroup O1 in adults 18 through 64 years of age traveling to cholera-affected areas UNMET NEED: Cholera, caused by Vibrio cholerae bacteria, acquired by ingesting contaminated …

FDA Approvals and Reviews: VAXCHORA vaccine, LIFESTENT vascular system – Drug and Device Digest Read More »

FDA BRIEF: WEEK OF MAY 2, 2016   NUPLAZID (pimavanserin) tablets Acadia Pharmaceuticals, San Diego, California, USA INDICATION:  Treatment of hallucinations and delusions associated with Parkinson’s  disease psychosis UNMET NEED:  ~ 50,000 Americans diagnosed with Parkinson’s disease each year Hallucinations or delusions can occur ~in as many as 50 percent of patients Can be profoundly disturbing and disabling REG …

FDA APPROVAL: NUPLAZID, KRYPTOR, – Drug and Device Digest Read More »

WHAT: Total prohibition on the current and future sales, distribution, and manufacturing of a medical device WHY:  Analyzing and weighing the risks and benefits the device poses to individuals. Can ban a device without actual proof of illness or injury, and only needs to find that a device has the potential to present the required …

Medical Device Bans – Drug and Device Digest Read More »

FDA News and Views: Orphan Drug Act, Continuous Manufacturing, Priority Therapeutic Areas Drug & Device Advisory Group 3 years ago FDA BRIEF: Week of September 11, 2017 FDA is Advancing the Goals of the Orphan Drug Act By: Scott Gottlieb, M.D., FDA Commissioner Orphan Drug Modernization Plan eliminate a backlog of about 200 orphan drug …

FDA News and Views: Orphan Drug Act, Continuous Manufacturing, Priority Therapeutic Areas Read More »

August 24, 2015August 24, 2015 Drug & Device Advisory Group FDA Briefs FDA News, Week of Aug 17, 2015 CDRH participation in the International Medical Device Regulators Forum (IMDRF)’s Regulated Product Submission Table of Contents (RPS ToC) Pilot Program. Developed harmonized In-Vitro Diagnostic (IVD) and non-IVD Tables of Contents (ToCs) for premarket clearance or approval. …

August 2015 – Drug and Device Digest Read More »