Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.
News|Articles|July 2, 2004
- Pharmaceutical Technology-07-02-2004
- Volume 28
- Issue 7
From CGMPs to the Critical Path: FDA Focuses on Innovation, Quality, and Continuous Improvement–Inside and Out
Author(s)Laura Bush
As FDA prepares for the Critical Path initiative, offices across the agency are expanding the use of the risk-based approach to regulation and applying a quality systems approach to internal operations.
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Articles in this issue
about 22 years ago
3M Drug Delivery Systemsabout 22 years ago
AccuRateabout 22 years ago
July 2004about 22 years ago
Investors Shy Away from Pharmaceutical Chemicalsabout 22 years ago
In the Spotlight-July 2004about 22 years ago
A Stability Program for the Distribution of Drug Productsabout 22 years ago
Politics Versus Science in Biomedical Research and DevelopmentAdvertisement
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Ronald Piervincenzi, USP, explains why manufacturers should act now and how benchmarking could reward reliable generic drug suppliers.
The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.
The agency issued a direct final rule that supports the use of innovative testing methods to limit the use of animals and maintain existing safety standards.
The FDA approves Inluriyo-Verzenio combo for ESR1-mutated breast cancer; EMBER-3 data double PFS, with supply chain and diagnostics implications for manufacturers.
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.
Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
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