CDRH Seeks Stakeholder Input on 2019 Guidance Priorities
FDA’s Center for Devices and Radiological Health called for feedback from stakeholders on its priorities for developing guidance for the year ahead. Source: The GMP Letter
Health Canada Maps Out Action Plan to Improve Device Safety, Quality
Health Canada released a three-part action plan aimed at improving how devices get on the market, strengthening monitoring and providing more information to consumers about the devices they use. Source:…
Notified Bodies Warn of Future Bottlenecks in Implementing New Device Regs
The European Association for Medical Devices of Notified Bodies (Team-NB) is sounding alarms over the shortage of notified bodies to conduct audits and certify devicemakers in time to comply with…
EMA Considers Electronic Product Information Standard for Drugs
The European Medicines Agency began a six-month public consultation Thursday for draft principles on a common EU standard for human drug electronic product information. Source: Drug GMP Report
FDA Releases Naloxone Drug Facts Labels to Spur OTC Development
FDA Commissioner Scott Gottlieb announced that the agency has developed easy-to-understand model drug facts labels (DFLs) to encourage drugmakers to develop an OTC version of the opioid overdose treatment naloxone.…
Italian Agency Hits Chinese Heparin Manufacturer for GMP Violations
The Italian Medicines Agency found serious GMP violations during an Oct. 31 inspection of a heparin manufacturing facility in China and recommended that the firm be prohibited from supplying crude…
483 Roundup: FDA Flags Seven Firms for Testing, Other Issues
The FDA cited seven drug manufacturers for significant problems identified during inspections, ranging from inadequate testing to a failure to secure analytical equipment. Source: Drug GMP Report
FDA Warns Akorn Over Conditions at Sterile Drug Facility
The FDA issued a warning letter to Akorn’s sterile drug manufacturing facility in Decatur, Illinois on Jan. 4 over poor aseptic conditions observed during an inspection last spring. Source: Drug…
FDA Denies Petition to Add Warning to Blood Thinner Labeling
The FDA has denied a petition from Public Citizen to add a boxed warning to the labeling for the blood thinner clopidogrel. Source: Drug GMP Report
FDA Issues New Guidance on Assessing REMS
The FDA released two draft guidances outlining the agency’s latest thinking on assessments of risk evaluation and mitigation strategy (REMS) programs. Source: Drug GMP Report