The FDA grants accelerated approval to subcutaneous amivantamab for head and neck cancer, extending the IV-to-subcutaneous shift in biologics formulation.
News|Articles|January 1, 2003
- Pharmaceutical Technology-01-01-2003
- Volume 27
- Issue 1
Technical Considerations for the Validation of Electronic Spreadsheets for Complying with 21 CFR Part 11
Author(s)Tuan T. Phan
Bridging the gap between compliant spreadsheet production and limitations in available technology can be achieved by the use of custom-created electronic solutions.
Advertisement
Articles in this issue
almost 24 years ago
Pharmaceutical Pricing and Innovation Key Issues for 2003almost 24 years ago
Procedures: Improving Their Qualityalmost 24 years ago
Drug-Carrier Screening on a Chipalmost 24 years ago
Outsourcing Outlookalmost 24 years ago
Pack EXPO International 2002 Proves Worth the Tripalmost 24 years ago
Analysis of the Indian Pharmaceutical IndustryAdvertisement
Related to this article
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.
FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.
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.
USP data show fewer US drug shortages but longer ones, averaging 5+ years. Drug shortages are an incentive problem, not a manufacturing mystery.
The pharmaceutical supply chain is a complex system with high stakes. USP provides insights on how it is helping industry navigate global disruptions and procurement issues.
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.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
Improving Oral Peptide Delivery Through Structural Modifications
2
Drapeau’s AI Deep Dive: The Price of Acceptance in Regulated AI
3
Regulatory Roundup—October 2026: FDA Advances Rare Disease Development and Transparency Efforts
4
PharmTech AI Pulse Check: AI Policies Become Regulators' Inspection Yardstick
5