Invalidated OOS results are ‘red flags’ during FDA inspections and ‘denying, delaying, limiting or refusing’ a drug inspection proposed by the agency could have serious consequence, participants at a recent webinar on best practices for responding to Form 483s and warnings letters heard.

Satish Reddy, president of the Indian Pharmaceutical Alliance and chair of Dr Reddy’s Laboratories, says that the government and domestic industry have to act promptly, and in tandem, to regain India’s glory days of dominance in active pharmaceutical ingredients and avoid a public health problem.

Association for Accessible Medicines interim CEO and general counsel Jeff Francer, in an interview with Generics Bulletin sister publication Scrip, discusses the industry body’s continued efforts to ensure that generics and biosimilars are not disadvantaged in the US by the brand name industry's commercial tactics or legal/regulatory moves, and outlines the 'enormous progress' made by generic firms on quality.