Archive for March 2018
Dr. Reddy’s Hit With 483 for Supplier Quality Agreements, CAPA Issues
The FDA issued Dr. Reddy’s a Form 483 after an inspection of its Medak, Telengana facility in India determined it did not establish quality agreements with material suppliers and failed to complete multiple CAPAs in a timely manner, among other violations. Source: Drug Industry Daily
Read MoreAppeals Court Stays PTAB Review Over Allergan/St. Regis Patent Deal
A federal appeals court delayed a Patent Trial and Appeals Board review of Allergan’s patents for its dry-eye drug Restasis until after a court hears oral arguments on jurisdictional issues. Source: Drug Industry Daily
Read MoreImpax Reaches $20 Million Midtrial Settlement With Retailers Over Pay-For-Delay Allegations
Impax Labs will pay $20 million to settle claims it kept its generic acne drug off the market in a “pay-for-delay” deal. Source: Drug Industry Daily
Read MoreGottlieb Stresses Importance of Patient Voice in Benefit-Risk Assessments
FDA Commissioner Scott Gottlieb announced an update of the agency’s framework for using benefit-risk assessments in drug reviews and said he wants to improve the assessments by making increased use of patient perspectives. Source: Drug Industry Daily
Read MoreJudge Strikes $235 Million Patent Infringement Verdict Against Teva
A Delaware judge threw out a 2017 decision that had Teva on the hook for more than $235 million over its generic for GlaxoSmithKline’s chronic heart failure and blood pressure drug Coreg (carvedilol). Source: Drug Industry Daily
Read MoreGAO: FDA’s Monitoring of Early Abortion Drug Does Not Raise Safety Concerns
The Government Accountability Office reviewed the FDA’s relabeling of Mifeprex — an early abortion pill covered by a risk evaluation and mitigation strategy — and concluded that the agency’s monitoring did not raise significant safety concerns. Source: Drug Industry Daily
Read MoreOIG: FDA Must Increase Education Outreach to Pharmacies on Drug Tracing Requirements
Most independent, chain and hospital pharmacies are implementing requirements for drug tracing but many are not properly reviewing the data, according to a new report from the HHS Office of Inspector General. Source: Drug Industry Daily
Read MoreFDA Issues First Required Inspections Report, Covering 2017
In its first required inspection metrics report for 2017, FDA officials found a median time of 102 days between inspection requests by the FDA to a facility and the beginning of inspections, and a median of seven days between the beginning of a pre-approval inspection and the issuance of a Form 483. Source: Drug Industry…
Read MoreAmgen Asks if Drug Suffixes for Biologics and Biosimilars Could Lead to Misbranding Charges
In comments on the FDA’s draft guidance on drug and biologics labeling, Amgen urged the agency to follow a precedent set by a previous agency opinion that a USP monograph title consisting of a core name without a suffix does not apply to biologics whose nonproprietary names include a suffix. Source: Drug Industry Daily
Read MoreAllerQuest Cited for Sterility, Air Control Concerns
The FDA issued a Form 483 to Plainville, Connecticut drugmaker AllerQuest for sterility issues and air control deficiencies after an inspection spanning from August to September. Source: Drug Industry Daily
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