Showing posts with label regulatory. Show all posts
Showing posts with label regulatory. Show all posts
Saturday, June 17, 2023

Regulatory Education for Industry (REdI) Annual Conference 2023 - Slides and Recordings

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Early this month, FDA conducted 'Regulatory Education for Industry (REdl) Annual Conference 2023'. This annual conference provided ...
Monday, August 22, 2022

Story of BrainStorm's Stem Cell Treatment for ALS - Criticality of the Statistical Analyses

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This past week, the biotech company BrainStorm announced the decision to submit a BLA to the FDA for NurOwn® (a stem cell treatment) for th...
Tuesday, February 08, 2022

FDA's Priority Review Voucher for COVID-19 Vaccine

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 To spur drug development in the under-developed area, FDA relies on various policies and programs to incentify the biotech and pharmaceutic...
2 comments:
Saturday, September 11, 2021

Afghan Withdrawal and Accelerated Approval for Aduhelm

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These two topics seem to be irrelevant at all, but have one thing in common: changing the subjects when the decision is questioned. For the ...
Sunday, May 23, 2021

Are we moving away from data listings now that the standard data sets (such as CDISC-compliant SDTM and ADaM data sets) are mandated by FDA?

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After a clinical trial is concluded, the statistical group (statisticians and statistical programmers) will generate the tables, listings, a...
Monday, December 28, 2020

120-Day Safety Update or 4-Month Safety Update - The Requirement for NDA/BLA

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After the new drug application (NDA) or biological license application (BLA) is submitted by the sponsor and is accepted by FDA, FDA reviewe...
2 comments:
Sunday, November 08, 2009

Pediatric use and geriatric use of drug and biological products

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In the United States, every marketed drug or biological product needs to have its product label or package insert. The product label contain...