From AI validation to microstructure imaging, AAPS PharmSci 360 speakers pushed toward faster drug development backed by stronger evidence. Here are PharmTech's biggest takeaways.
|Articles|November 2, 2003
- Pharmaceutical Technology-11-02-2003
- Volume 27
- Issue 11
FDA Seeks Risk-Based Inspection Program
Author(s)Jill Wechsler
FDA's new policies intend to make GMP inspections more efficient and apply to stricter rules to high-risk products and processes.
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Articles in this issue
about 23 years ago
FDA Will Drive Changes for Contract Businessabout 23 years ago
In the Spotlight--Decemberabout 23 years ago
Novemember 2003about 23 years ago
Routine Sample Size for a Retest Procedureabout 23 years ago
November 2003about 23 years ago
Clearing Regulatory Hurdlesabout 23 years ago
Improving Protein Capture for Transgenic Drug ProcessingAdvertisement
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The FDA approves asundexian, the first factor XIa inhibitor, cutting stroke risk 26% and setting a regulatory benchmark for factor XI drug developers.
Panelists on the PharmTech AI Pulse Check weigh a December AI playbook, EMA/MHRA moves, PCCP accountability gaps, and MCP-ready regulatory guidance.
No operator touches a CAR-T batch before demonstrating proficiency. Generative AI users should meet the same standard, and a higher one, because an AI error does not stay inside one batch.
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.
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.
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