FTC’s Shire Appeal Denied in Fight Over Citizen Petitions
The U.S. Court of Appeals for the Third Circuit upheld a Delaware federal district court’s decision to throw out an FTC lawsuit that sought to curb alleged misuse of citizen…
Novartis Considers Appealing $1.5 Million Whistleblower Verdict
Novartis is hinting that it will appeal a New Jersey jury’s verdict awarding $1.5 million to a former executive who alleged that the company created a bogus drug study to…
BSI Warns Devicemakers to Migrate CE Certificates Before Brexit Deadline
With a looming hard Brexit exit less than 60 days away, BSI is warning devicemakers that their CE certificates in the UK could become invalid if the UK and EU…
FDA Cites Six Firms for GMP, Other Issues
The FDA rapped six device facilities for a variety of deficiencies identified during inspections, including problems with CAPAs and medical device reporting. Source: The GMP Letter
China Introduces Routine Overseas Device Inspections
China’s National Medical Products Administration is increasing its scrutiny of foreign manufacturers and will begin routine, risk-based inspections of foreign facilities to confirm they are in compliance with Chinese regulations.…
HSCC Introduces Plan for Cybersecurity ‘By Design’
The Healthcare and Public Health Sector Coordinating Council (HSCC) has developed a new guide for managing the security of medical devices. Source: The GMP Letter
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
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