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Courier Expert Opinion: A Critical Factor in Safeguarding the Success of the FDA's Accelerated Approval Program

 Last Update: 2022-02-20
 Source: Internet
 Author: User

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The Accelerated Approval Program is a regulatory measure by the FDA to bring innovative treatments to patients as quickly as possible, allowing them to be approved for marketing based on surrogate endpoints
.

Completing confirmatory studies as quickly as possible is critical to the success of accelerated approval programs , a number of regulatory and industry experts said at CERSI’s Innovations in Regulatory Science Summit recently .

Completing a confirmatory study as soon as possible is critical to the success of an accelerated approval program

Dr.
Julie Beaver, chief of medical oncology at the FDA's Oncology Center of Excellence, said accelerated approvals in general have done a great job of bringing cancer therapies to patients faster
.

There are currently more than 160 accelerated approvals in oncology, with approximately half of those approvals confirming clinical benefit in a median of 3 years

Early agreement to develop a program to generate confirmatory evidence will influence FDA's risk-benefit decision and support accelerated approval decisions

Drug developers are also eager for confirmatory data, said BIO President and CEO Dr.
Michelle McMurry-Heath
.

"They want to be able to iterate further on their innovations

She also said that building an infrastructure to rapidly collect this type of data requires the FDA, private payers, industry and other parties to collaborate to find a pragmatic way to collect confirmatory data faster and at lower cost, while reducing burden on patients

Original in English: https://endpts.

https://endpts.
com/califf-on-accelerated-approvals-companies-need-to-do-more-work-before-fda-says-ok/

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