MDUFA IV Would Raise Fees, Reduce Time for Decisions December 16, 2016 The FDA has agreed to cut time-to-decision goals for 510(k)s from 124 to 108 days. Read More
High Court Refuses to Hear Case on Six-Month Wait for Biosimilar Launch December 16, 2016 The high court denied a petition from Apotex to overturn a federal appeals court ruling. Read More
Australia Outlines System for Notified Bodies to Assess Devices, Diagnostics December 15, 2016 The measures are part of the TGA’s regulatory reforms. Read More
FDA Denies Adapt Pharma’s Petition for Higher Standards to Approve Naloxone Generics December 15, 2016 The petition requested an FDA advisory committee meeting on the optimal dose for naloxone. Read More
EU Suspends Endologix’s CE Mark December 14, 2016 The device is still available in the U.S. and Japan. Read More
Califf and 14 FDA Officials Look to Temper Expectations for Real-World Evidence December 14, 2016 They cautioned against expectations for “quick wins” in saving time and money. Read More
CDSCO of India Issues Recall for JMS Infusion Set December 13, 2016 The product label is not approved by CDSCO of India for indicated shelf life. Read More
Sun Pharmaceuticals Halol Plant Still in Trouble with FDA after New Report December 13, 2016 Violations included unexplained failures of drug batches and failures to maintain a clean area in aseptic processing. Read More
Congress Passes 21st Century Cures Act December 12, 2016 The FDA institutes will be coordinating product reviews among other approvals. Read More
Centurion Issues Recall on Multi-Med Single Lumen Catheters December 12, 2016 The catheter is used to sample blood and administer drugs or fluids. Read More
Gordian Surgical Gets FDA Clearance for TroClose1200 December 9, 2016 The device opens and closes surgical procedures. Read More
New Drugs Director John Jenkins to Retire from FDA in January December 9, 2016 Jenkins has led OND since January 2002. Read More