• Humanitarian Device Exemption (HDE) submissions; (人道主义设备豁免申请,简称HDE) • Biologics License Application (BLA) submissions; (生物制剂许可,简称BLA) • Investigational New Drug (IND) submissions. (新药研究申请,简称IND) 《指南》共从以下三个方面为相关产业工作人员提供了建议: 一般原则 ...
3. What is an appropriate length of time between submission of modules? You should provide the approximate timing of the submission of each PMA module in the PMA shell to FDA. It is FDA’s intent that applicants who choose to participat...
3. What is an appropriate length of time between submission of modules? You should provide the approximate timing of the submission of each PMA module in the PMA shell to FDA. It is FDA’s intent that applicants who choose to participate in the PMA Modular Review Program would submit modules...
Patritumab Deruxtecan BLA Submission Receives Complete Response Letter from FDA Due to Inspection Findings at Third-Party Manufacturer BASKING RIDGE, N.J. & RAHWAY, N.J., June 26, 2024 – The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Bi...
B. PMA Modules 1. Submission of Each PMA Module When submitting a module, you should clearly identify the submission as a module and reference the previously assigned shell number (and module number) in the cover letter. As outlined in Attachment II Sample PMA Shell, you should include the ...
The FDA accepted theBLA submission for obe-cel, a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, in R/R B-cell ALL, according to Autolus Therapeutics.1 A PDUFA target action date of November 16, 2024, has been issued. ...
“The rapid completion of this BLA submission is a critical step forward in our mission to bring our first proprietary combination regimen to patients with both treatment naïve and relapsed or refractory chronic lymphocytic leukemia,” said Michael S. Weiss, executive chairman and chief ...
研发公司可以在提交上市申请（NDA/BLA）时向FDA滚动递交（rolling submission）新药研究资料。这些优惠政策...
their July 2023 CRL. No concerns relating to safety or efficacy were noted in the letter, and we remain confident in the robustness of the clinical data package included with the initial BLA submission,” Leonard Mazur, chairman and chief executive officer at Citius, said in the press rele...
“As planned, the Lerodalcibep BLA has been submitted to the FDA, and we are now preparing a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for submission by mid-2025,” said David Cory, CEO of LIB Therapeutics. “We look forward to working with regulators...