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.
|Articles|November 7, 2013
BIO Throws its Support for Start-up Jobs and Innovation Act
Author(s)Pharmaceutical Technology Editors
Biotechnology Industry Organization President James Greenwood writes senators in support of Start-up Jobs and Innovation Act.
Advertisement
The Biotechnology Industry Organization (BIO) has
“Many research-intensive companies rely on private investment to support their groundbreaking R&D. Because of the long research process intrinsic to scientific advancement, growing innovators operate without product revenue and thus cannot use the sale of one product to finance the development of another. The investment dollars that fund the decade-long, billion-dollar biotech pipeline are supporting the next generation of breakthrough technologies,” says BIO President and CEO James C. Greenwood in a
“Innovative biotech companies at all stages of the development process are working toward next generation technologies to heal, fuel, and feed the world. [The] Start-up Jobs and Innovation Act will support the early-stage research critical to bringing these breakthroughs to the world,” says Greenwood.
Advertisement
Related to this article
Lori Dingledine, QC Director Microbiological Control and GTIC Operations at Genentech, provided input on the regulations surrounding raw material manufacturing and use for ATMPs in a presentation at the 2026 PDA/FDA Joint Regulatory Conference.
2026 approvals, clinical data, and licensing deals are advancing subcutaneous biologics, reducing patient burden, and reshaping biopharma drug strategy.
Karthik Iyer, Eli Lilly, details an AI system linking GMP findings, audits, and deviations for cited, inspection-ready regulatory intelligence.
At the PDA/FDA Joint Regulatory Conference 2026, Helen Motamen, MS
global head, Sanofi Quality Audit, Inspection, Intelligence & Advocacy, at Sanofi, provided advice for creating a strong internal audit program.
AI can turn medical device risk management into a continuous signal.
On PharmTech.com this week, coverage of upcoming events continued, experts continued to discuss the use of AI in pharma, and validation in oral solid dosage product production was emphasized.
This article explores the historical use of silicone oil in the performance of primary drug product packaging; design of experiment test results for selection of the cleaning agent and CCPs; assessment of visible residue limits and Fourier-transform infrared spectroscopy surface analysis; and setting health-based exposure limits for silicone oil using a non-uniform distribution model, and a previously published permitted daily exposure.
Advertisement
Advertisement