20 years later, signs that this time the US EU mutual recognition agreement won’t fizzle.
Why, 20 years later, have the US and the EU agreed on another go at mutual recognition for drug GMP inspections?
At first blush, the timing couldn’t be any worse.
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In its latest attempt to curtail generic versions of Hetlioz, Vanda Pharmaceuticals asked FDA Commissioner Martin Makary to reverse a previous agency decision upholding two ANDA approvals, claiming an “unacceptable culture of bias toward approving generic drugs” at the agency.
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
Health Canada has approved four new drugs and 12 label variations so far this year via Project Orbis, a combined figure that already exceeds the annual approval figures for the two previous years. The agency explains the factors that impact annual approvals and highlights the pathway’s benefits.
