The PharmTech AI Pulse Check panel discusses why MHRA and FDA oversight of pharma AI continues past go-live, and who validates the regulators' own AI.
|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 grants accelerated approval to subcutaneous amivantamab for head and neck cancer, extending the IV-to-subcutaneous shift in biologics formulation.
Jaenisch, Muraru, and Pandey discuss how regulators will audit pharma against its own AI policies and ways QA and regulatory teams can build defensible, inspection-ready AI practices.
The FDA approves VOCERYQ, the first DNA medicine, for RRP surgery reduction, raising plasmid, drug-device, and confirmatory trial manufacturing demands.
Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
Manish Baviskar, Hubot CDMO, explains which AI skills validation engineers need first and why AI model updates must go through GMP change control.
Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.
Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.
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