▎WuXi AppTec Content Team Editor
This Issue
[1] US FDA launches drug review pilot program, which is expected to speed up the review of new drugs
[2] The Center for Drug Evaluation of the State Food and Drug Administration of the People’s Republic of China issued a draft of “Guidelines for the Identification, Treatment and Evaluation of Drug-Induced Liver Injury in Clinical Trials”
[3] U.S. FDA Announces Fiscal Year 2023 PDUFA Fees
U.S. FDA launches drug review pilot program, expected to speed up new drug review
A few days ago, the US FDA announced the launch of the Split Real Time Application Review pilot program, referred to as the STAR Program. The goal of this pilot program is to shorten the time between the date of filing an application and the date of the FDA’s decision, thereby giving patients with unmet needs earlier access to innovative treatments.
This pilot program allows drug developers to submit regulatory applications in two parts. The first part can be submitted after the top-line results of the pivotal clinical trial have been obtained. The FDA will begin reviewing the first part of the application, speeding up the review process. Additional application content can be submitted in the second part that follows.
This pilot program has similarities to the FDA Oncology Center of Excellence’s Real-Time Oncology Review (RTOR). However, its use is not limited to anti-cancer therapies, but can be applied to Supplemental New Drug Applications (sNDAs) and Supplemental Biologics License Applications (sBLAs) in all fields. In addition, applications to this program are required to meet a number of criteria, including:
1. There is clinical evidence that the drug shows significant improvement over other available therapies, as assessed by the same criteria as for breakthrough therapy designation or advanced regenerative therapy designation.
2. Medications are used to treat serious illnesses with unmet medical needs.
3. The application does not include other factors that may lead to longer review times (eg the need for a REMS assessment).
Related Links:
https:https://www.fda.gov/drugs/development-resources/split-real-time-application-review-star
The Center for Drug Evaluation of the State Food and Drug Administration of the People’s Republic of China issued a draft of “Guidelines for the Identification, Treatment and Evaluation of Drug-induced Liver Injury in Clinical Trials”
On October 8, the Center for Drug Evaluation of the State Drug Administration of China issued a draft for the “Guidelines for the Identification, Treatment and Evaluation of Drug-Induced Liver Injury in Clinical Trials”. The opinion draft pointed out that the purpose of this guideline is to guide the assessment of the potential of Drug-Induced Liver Injury (DILI) in drug clinical trials, which is applicable to chemical drugs and biological products.
The draft is currently in the stage of soliciting comments and suggestions, and the time limit is 1 month from the date of publication.
Related Links:
https:https://www.cde.org.cn/main/news/viewInfoCommon/78e34ca26453d2eeeda183cfbc3cc3c2
US FDA Announces Fiscal Year 2023 PDUFA Fees
The U.S. Food and Drug Administration (FDA) recently released the PDUFA fee for fiscal year 2023, which is the fee the FDA collects from drug developers, generic drugs, biosimilars, and medical device developers when processing regulatory applications. See the relevant link for a list of specific fees.
Related Links:
https:https://www.raps.org/news-and-articles/news-articles/2022/10/fda-posts-fy2023-user-fee-tables
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