This week addressed AI accountability, CPHI award winners, NFC anticounterfeiting, first-in-class FDA approvals, and a shelved FDA voucher pilot lead this week’s roundup.
|Articles|July 1, 2001
- Pharmaceutical Technology-07-02-2001
- Volume 25
- Issue 7
Reflections on Changes at FDA
A former deputy director of the Office of Pharmaceutical Sciences takes a personal look back at 25 years of change at FDA's Center for Drug Evaluation and Research.
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Articles in this issue
over 25 years ago
Musings on the Past 25 Yearsover 25 years ago
Deliver the Doseover 25 years ago
Middle-European Pharmaceutics in a Changing Worldover 25 years ago
The BCS: Where Do We Go From Here?over 25 years ago
From Inactive Ingredients to Pharmaceutical Excipientsover 25 years ago
Am I Going Backwards?over 25 years ago
The Filter Scene: Old and Newover 25 years ago
Catching Up with Expert Systemsover 25 years ago
25 Years of Change in the Parenteral Technology FieldAdvertisement
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Cole and Jaenisch explain why defending against AI poisoning in pharma manufacturing calls for a data steward role, immutable instruction ledgers, and automation.
Gloveless isolators don’t end interventions. Learn to assess intervention dependency in robotic aseptic filling and when glove ports are justified.
Terry Katz, CEO and co-founder of ForgeStop Technology Corporation, explains how the company’s product is worth the investment by protecting products and patients.
The FDA has shelved its National Priority Voucher pilot, leaving sponsors that built CMC and launch-readiness plans around 1- to 2-month reviews facing uncertain timelines.
Regulators will test pharma companies against their own internal AI policies. Jaenisch, Muraru, and Pandey explain how to build defensible, inspection-ready AI practices.
Terry Katz, CEO and co-founder of ForgeStop Technology Corporation, explains how its connected technology can enhance anticounterfeiting and how data are handled within the product.
Celtic Renewables won the CPHI Award for Sustainable Pharma Excellence for its green chemicals used in pharmaceutical manufacturing. Bettina Brierley, chief commercial officer, talks about the adoption, capacity, and pricing of biosolvents.
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