Thought Leadership Series: Leveraging FDA expedited review programs

八月 25, 2021 at 2:00 p.m. ET The U.S. FDA offers four distinct programs to speed the development and availability of drugs that address an unmet medical need in the treatment of a serious or life-threatening conditions: Priority Review, Accelerated Approval, Fast Track, and Breakthrough Therapy. Additionally, other programs, such as the Regenerative Medicine Advanced … Continued

Plain Language Summaries & Patient Engagement in Pediatrics

Plain language summaries (PLS) of clinical trial results ensure that study participants are informed about study results and that they understand the value of their contribution to science and public health. Patient engagement is key to support PLS development. Factoring patient insights and experience into PLS development drives improvement of PLS quality, readability, and comprehension. … Continued

Custom Result: IND early dev

Custom Result: IND early dev

Tips For A Successful eCTD Conversion

With the May, 2018 FDA mandate quickly approaching, conversion of paper IND’s, NDA’s, and DMF’s to eCTD format must happen soon. Here are some tips for a successful eCTD conversion. It is important to note that once an eCTD submission has been made to an application all subsequent submissions to that application must also be … Continued

Converting a Paper IND to eCTD Format

Conversion of a paper IND to eCTD format can be done at any time the sponsor is ready to implement eCTD. It is important to note that once an eCTD submission has been made to an application all subsequent submissions to that application must also be in eCTD format. Typically, the first submission sent to … Continued

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