For Indications and Usage section of some drugs, such as anti-cancer agents, it may be enough merely to state that accelerated approval was based on a specific surrogate; however, labeling for other types of drugs may need to reflect the clinical outcomes that are expected but not yet established, agency says.
The US FDA’s final guidance on accelerated approval drug labeling distinguishes between therapeutic settings where surrogate endpoints are widely recognized, such as oncology, and those where such endpoints may be less well understood.
For the Indications and Usage section of some drugs, such as anti-cancer agents, it may be enough merely to state that accelerated approval was based on a specific surrogate or intermediate clinical endpoint, and that continued approval may be contingent upon
New CBER Director Prasad will "unleash a massive" framework on vaccines, FDA Commissioner Marty Makary said 15 May, raising questions about the impact on products nearing approval.
Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.
With an FDA review ongoing, Kennedy’s admission, made during a Senate hearing on the Health and Human Services Department’s budget request, suggests political officials could supersede scientific decisions.
