The FDA should clarify some key definitions in its draft guidance on drug supply chain security, according to two industry groups. Source: Drug Industry Daily

The FDA released its justification for the administration’s fiscal year 2019 budget request, detailing how the agency would allocate funds to boost pharmaceutical innovation, combat the opioid crisis and reform…

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…

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.…

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…

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…

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…

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…

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…