Judge Throws Out Teva Lawsuit Against FDA Generic Exclusivity Policy
A federal judge ruled Teva can’t challenge the FDA’s new policy on generic exclusivity because the drugmaker has not proved a danger of imminent injury. Source: Drug Industry Daily
FDA Warns CanaRx Over Drug Distribution ‘Scheme’
The FDA hit Canadian drug distributor CanaRx with a warning letter, citing the company for supplying unapproved versions of FDA-cleared drugs. Source: Drug Industry Daily
OGD Reports Continued Increase in First-Time Generic Approvals in 2018
The FDA’s Office of Generic Drugs released its annual report for 2018, highlighting a steady increase in first-time generic approvals and the green lighting of more than 1,000 generic drugs.…
Spanish OTC Drugmaker Nailed for Testing, Records
The FDA issued a warning letter to an OTC drug manufacturer in Catalonia, Spain, for inadequate testing of released drug products and incomplete batch records. Source: Drug Industry Daily
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