US FDA defends accelerated approvals; rejects GAO's suggestions
This article was originally published in SRA
The US Food and Drug Administration has conceded that its oversight of postmarketing studies for drugs cleared under the accelerated approval process has been inadequate in the past. But the agency has rejected a critical new government watchdog report that, it says, focuses on a limited number of drugs with which there have been problems under the process1.
You may also be interested in...
A new draft guideline explains how sponsors of subsequent-entry orally inhaled drug products can comply with the Canadian requirement for demonstrating equivalence to the reference product.
While good clinical practice inspectors in the UK and the US collaborate on matters of common interest, they say that mutual recognition is simply not possible.
Whoever takes over as chair of the Medicines and Healthcare products Regulatory Agency will play a key role in its plans to deliver a program of “ambitious business change.”