FDA’s OTP Town Hall Clarifies CMC and Facility Readiness Standards for Gene Therapy BLAs
The FDA’s Office of Therapeutic Products (OTP) within the Center for Biologics Evaluation and Research (CBER) hosted its Virtual...
Moe Alsumidaie
FDA’s 2025 Roadmap for Generics: Modernizing Policy, Transparency, and Global Alignment
At the Advancing Generics 2025 forum, FDA officials, policy leaders, and industry executives outlined the next phase of the...
Why Pharma AI Pilots Fail — And How Medical Affairs & Commercial Can Actually Win
At first glance, it looks like a paradox: pharma companies pour billions into AI pilots, and yet the success...
The Inflection Point for Medical Affairs: A Preview of the 2025 Veeva Commercial Summit
Medical Affairs has never carried more strategic weight—or faced greater pressure to prove its value. Across Europe, leaders are...
The OTC System That Let Safety Risks Linger for a Decade — And the FDA’s Quiet Move to Fix It
In 2023, more than 300 children died across multiple countries—Gambia, Uzbekistan, and Cameroon—after taking contaminated cough syrup. The syrups...
SSRIs in Pregnancy: FDA’s Blind Spot and the Battle Over Maternal Mental Health
She thought she was doing the right thing. At 29, newly married and planning to start a family, her...