CMC Archives — BLA Regulatory

Tag Archives: CMC

Home Posts tagged "CMC"

Can Your Biosimilar Skip Phase 3 Trials? US FDA’s Biosimilar Rules Explained

By: Yuka Osada
On: June 25, 2026

Can Your Biosimilar Skip Phase 3 Trials? US FDA’s Biosimilar Rules Explained

U.S. FDA Tightens Oversight of Cross-border Cell Exports!

By: Yuka Osada
On: April 23, 2026

U.S. FDA Tightens Oversight of Cross-border Cell Exports!

US FDA CMC Strategy: CGT Comparability and BLA Readiness

By: Yuka Osada
On: March 19, 2026

US FDA CMC Strategy: CGT Comparability and BLA Readiness

FY 2026: FDA Device Registration, Listing & User Fees

By: Yuka Osada
On: February 19, 2026

FY 2026: FDA Device Registration, Listing & User Fees

PreCheck Program: FDA’s Roadmap for US Drug Manufacturing

By: Yuka Osada
On: February 12, 2026

PreCheck Program: FDA’s Roadmap for US Drug Manufacturing

Eye on the Horizon: The $79B Evolution of Ophthalmic Therapies

By: Yuka Osada
On: January 22, 2026

Eye on the Horizon: The $79B Evolution of Ophthalmic Therapies

Navigating the 2026 “CMC Cliff” for AAV Gene Therapy

By: Yuka Osada
On: January 15, 2026

Navigating the 2026 “CMC Cliff” for AAV Gene Therapy

U.S. vs. Foreign Sponsors: Who Really Manages Drug Shortages?

By: Yuka Osada
On: October 1, 2025

U.S. vs. Foreign Sponsors: Who Really Manages Drug Shortages?

Registration & Listing of Cosmetic Facilities and Products in the US

By: Yuka Osada
On: September 17, 2025

Registration & Listing of Cosmetic Facilities and Products in the US

FDA Expands Surprise Inspections at Overseas Manufacturing Sites

By: Yuka Osada
On: August 20, 2025

FDA Expands Surprise Inspections at Overseas Manufacturing Sites