Canadian Ambassador, Distributors Reject U.S. Import Plan
Drug imports to the U.S from Canada “will have little or no impact on U.S. drug prices,” and will cause problems for Canadians, according to Canada’s acting Ambassador to the…
California Drugmaker Rapped for Data Backups, Other Violations
The FDA cited a Huntington Beach, Calif., drug manufacturer for four violations at its facility, including a lack of data backups. Source: Drug Industry Daily
Top Warning Letter Trends of 2019
The FDA’s warning letters for 2019 once again targeted many familiar GMP failures, such as quality units that either lacked or failed to follow written procedures. Source: Drug Industry Daily
2019 in Review: A Flurry of Major Drug Mergers and Acquisitions
2019 was one of the biggest years on record for pharma mergers and acquisitions, including the third largest acquisition of all time — Bristol-Myers Squibb’s $74 billion acquisition of Celgene.…
Teva Called Out for Complaint Handling, Written Procedures
The FDA hit Teva with a Form 483 for its handling of complaints and other deficiencies at its facility in Jerusalem, Israel. Source: Drug Industry Daily
Australian Court Finds J&J Liable for Mesh Injuries
The Federal Court of Australia has found Johnson & Johnson responsible in a lawsuit by more than 1,350 women over injuries linked to failures of its pelvic mesh. Source: The…
Health Canada Announces New Medical Device Directorate
Health Canada is creating a stand-alone Medical Devices Directorate (MDD) within its Health Products and Food Branch that will take a “lifecycle approach” and also take on postmarket functions currently…
483 Roundup: FDA Flags Six Devicemakers for GMP Lapses
The FDA cited six device manufacturers for GMP and other violations found during agency inspections. Source: The GMP Letter
Lawmakers Say Implant Claims Should Include UDIs
Sens. Chuck Grassley (R-Iowa), Elizabeth Warren (D-Okla.) and three representatives urged the Centers for Medicare & Medicaid Service to begin including information from unique device identifiers (UDIs) for high-risk implants…
Industry Urges Australia to Follow International SaMD Classifications
The proposal by Australia’s Therapeutic Goods Administration to align its regulation of software as a medical device with the EU’s approach drew general support from stakeholders, with some also urging…