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Latest From Actavis Group

Aducanumab Review: Looking For Precedents – Long Ago And Far Afield

The run-away US FDA advisory committee review of Biogen’s Alzheimer’s candidate was highly unusual. But like most things at the agency, not entirely unprecedented.

Advisory Committees Drug Approval Standards

Spike In Drug Recalls Expected As US FDA Resumes Inspections, Targeting COVID-19-Related Problems

Attorneys and recall consultants say any firm distributing products associated with COVID-19 should expect to receive the highest level of scrutiny as the US FDA resumes inspections and uses its enforcement muscle to prohibit companies from making adulterated products, such as hand sanitizers, or making fraudulent claims.

Consumer Recalls

Experts Predict Spike In Drug Recalls As US FDA Inspections Resume

Legal experts say any firm distributing products associated with COVID-19 should expect to receive the highest level of scrutiny as the US FDA resumes inspections and uses its enforcement muscle to prohibit companies from making adulterated products, such as hand sanitizers, or making fraudulent claims.

Manufacturing Quality

US Supreme Court Will Not Review Contrave Case

The US Supreme Court has turned down a request by Teva’s Actavis to review a ruling that upheld a patent protecting Nalpropion’s Contrave until 2030, despite the generics firm pointing out that the exact terms of a patent claim were not present in its specification.

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