Archive for March 2018

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

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

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

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

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

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

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

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…

In comments on the FDA’s draft guidance on drug and biologics labeling, Amgen urged the agency to follow a precedent set by a previous agency opinion that a USP monograph title consisting of a core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

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