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Latest From Covis Pharma

US FDA’s Non-Cancer Accelerated Approval Drugs Get Their Own Public Databases

Accelerated Approval Program web page links to searchable databases for accelerated approvals of infectious disease products, vaccines, and other nonmalignant indications. New databases, which include products that converted to regular approval or were withdrawn, are modeled after Oncology Center of Excellence’s cancer drug databases that debuted in 2021.

Review Pathway Post Market Regulation & Studies

US FDA Says Confirmatory Trials Should Start Before Accelerated Approval But Is Not ‘Dogmatic’

Beginning confirmatory trials before the accelerated approval is granted shortens the time between clearance and the confirmation of benefit, when patients are at risk, said Oncology Center of Excellence Director Richard Pazdur.

Clinical Trials Review Pathway

N Of 2: Reflections On The Makena, Avastin Accelerated Approval Withdrawal Hearings

Despite major differences in the sponsors, drugs and circumstances, the outcomes from the hearings on Makena’s continued availability and Avastin’s breast cancer indication were strikingly similar, with overwhelming votes in favor of withdrawal. In the process, however, both sponsors gained extra commercial time for their products.

Outlook 2023 Review Pathway

Vanda Objects To FDA’s ‘Highly Prejudicial’ Hearing Process And ‘Extra-Regulatory’ Requirements

Vanda says FDA improperly requires it to disprove all alleged deficiencies in its Hetlioz application for jet lag. Contentious approach to notice of opportunity for hearing contrasts with that of Intarcia and Lexicon, which also seek hearings over FDA’s proposal to refuse their applications.

Drug Review Drug Approval Standards
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