The FDA approves Inluriyo-Verzenio combo for ESR1-mutated breast cancer; EMBER-3 data double PFS, with supply chain and diagnostics implications for manufacturers.
|Articles|April 2, 2020
- Pharmaceutical Technology-04-02-2020
- Volume 44
- Issue 4
Pharmaceutical Technology North America, April 2020 (PDF)
Click the title above to open the Pharmaceutical Technology April 2020 issue in an interactive PDF format.
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This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
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Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
PharmTech spoke with Tara Dougal, event director for pharma at Informa Markets, about trends impacting the pharmaceutical industry and how CPHI Milan is addressing these areas this year.
Andrew Parker, PhD, executive drug development consultant, Quotient Sciences, explains how AI is integrated into pharmaceutical development.
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