What FDA Guidance Documents Can Drugmakers Expect in 2022?
March 25th, 2022 // 1:17 pm @ jmpickett
Every year, FDA’s CDER and CBER plan the priorities they want to deal with in industry guidance and offer help to the industry on particular regulations that may be hard to understand. This has been the case in recent years with CAR-T treatments and gene therapies. But FDA also has offered new guidance in recent times on simpler matters, such as how to respond to a 483.
FDA always stresses that its guidances aren’t legally enforceable, pharmaceutical companies still read every one and may offer public comments that indicate how specific areas of pharmaceutical development are going.
The CDER list for 2022 has several guidances that have been brought back from previous years, and there are new ones, too.
For example, CDER plans on issuing a new guidance for protocol deviations in clinical trials. It also intends to build on several new data-related guidance docs from last year. It also plans to release a new guidance called Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products. Another pending guidance is Using Clinical Practice Data in Randomized Controlled Trials (RCT) for Regulatory Decision-Making for Drug and Biological Products.
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The COVID-19 pandemic has led to severe drug shortages, so FDA intends to issue a new guidance about risk management plans that pharma companies need to use to deal with possible drug shortages.
Other guidances that will be issued in 2022 that were mentioned in previous years include one on fines for organizations that don’t meet accelerated drug approval post-marketing requirements. This has been on the CDER list since 2018. Also to be released is an update on FDA’s 2016 Q&A guidance concerning expanded access. This is another agency program that has garnered much interest since the COVID-19 pandemic started.
Another guidance of interest on deck for 2022 is on considerations for rescinding breakthrough therapy designations and a revised draft guidance on 6-month exclusivity for generic drug companies.
CBER also issued its own guidance list for 2022, including one focusing on human gene therapy products that use genome editing. Another will soon be issued on how to develop CAR-T therapies.
