The deadline to comment on FDA's generative AI paper is Oct 19, 2026. We explain why professionals in pharma manufacturing should weigh in.
|Articles|May 2, 2003
- Pharmaceutical Technology-05-02-2003
- Volume 27
- Issue 5
Drug Safety in the Limelight
Author(s)Jill Wechsler
FDA resolves the bar code labeling debate, releases its GMP requirements for dietary supplements, and proposes a comprehensive adverse-event reporting system.
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The FDA expanded Anktiva to BCG-unresponsive papillary-only NMIBC using existing CIS trial data, a precedent with implications for development timelines and supply planning.
Jaenisch, Muraru, and Pandey join PharmTech's Cole to discuss FDA's generative AI paper, ARPA-H's SURPASS trials, and AI accountability.
Richard Jaenisch explains what FDA's real-world use case database means for CMC and quality teams navigating NAMs.
Richard Jaenisch examines whether FDA's NAM pathway truly shortens drug pipelines or just shifts the evidentiary burden elsewhere.
Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.
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