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    Home > Medical News > Medical World News > FDA publishes new drug applications requiring submission of pediatric research materials for cancer drug use

    FDA publishes new drug applications requiring submission of pediatric research materials for cancer drug use

    • Last Update: 2019-12-26
    • Source: Internet
    • Author: User
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    Which targets are involved in the application of new drugs for cancer drug use and the application of biological product license, and which pediatric research materials need to be submitted at the same time? On December 12, the FDA released a draft guideline for the submission of pediatric research materials for cancer drug use According to relevant laws and regulations, from August 18, 2020, pharmaceutical companies that are expected to submit new drug application (NDA) or biological product license application (BLA) to FDA will carry out Pediatric Evaluation on some molecular targeted tumor drugs Dr Brett giroir, acting director of FDA, said that according to the revision of the federal food, drug and cosmetic act in the FDA reauthorization act 2017, FDA has a new way to evaluate some new cancer drugs that may be used in children's cancer treatment The newly published draft guideline aims to implement the revised requirements and provide the basis for the pharmaceutical industry, clinical researchers and ethics committee to carry out pediatric research on molecular targeting (referred to as "target" in the guideline) The draft guide describes the circumstances in which the evaluation materials need to be submitted by the sponsor and what factors should be taken into consideration Specifically, if the application for the original new drug or biological product license for a new active ingredient is for adult patients, but it involves the molecular target determined by FDA that is substantially related to the growth and progress of children's cancer, the required molecular target children's Cancer Research Report must be submitted when submitting the listing application Unless the requirement is waived or postponed The 13 page draft guidelines describe how FDA determines whether molecular targets are "substantially related to the growth or progression of childhood cancer," including information on exemptions and extensions To help relevant parties make decisions, more than 200 molecular targets were announced on the official website of the FDA oncology center of excellence (OCE) These targets include potential targets related to the growth or progression of childhood cancer based on existing evidence and / or biological mechanisms, and early pediatric evaluation of these drugs and biological products is required In addition, there is evidence that there are targets unrelated to the growth or progression of cancer in children; drugs targeting these targets can be exempted from relevant studies The draft guidance states that there is insufficient evidence for FDA to determine whether they are "substantially related" or "substantially unrelated" molecular targets and will not be included in the target list The relevant list will be updated regularly to reflect the specific determination results of the correlation of other relevant molecular targets The draft guidelines also include details of what should be included in the initial paediatric study plan, as well as the proposed studies The draft guidelines also list other considerations for rare cancers It should be noted that the draft guideline only covers drug development under Part 505 of the federal food, drug and Cosmetic Act, and does not cover drug development for children under the paediatric research Equity Act (PREA) and part 505a of the federal food, drug and Cosmetic Act Original title: viewpoint FDA publishes draft guidance: which new drug applications need to submit pediatric research materials for cancer drug use? A kind of
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