Article

New CBER Guidance, Posted 11 January 2002

Author(s):

BioPharm International Editors

Guidance for Industry: General Principles of Software Validation; Final Guidance for Industry and FDA Staff

Newsletter

Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.

Subscribe Now!
Related Videos
Behind the Headlines, Episode 23: Patent Cliff Deals, Tariff Pressures, and the In Vivo Cell Therapy Bet
Related Content
Industry inspector team working, QC staff work checking machine operation for safety and hygiene | Image Credit: ©Quality Stock Arts – stock.adobe.com
August 31st 2025

New Year, Same Challenges: Pharma’s Ongoing Struggle with FDA 483s

Patrick Falvey Georgia Sloboda Sarah DeDonder Lauren Schoukroun-Barnes
The Future of Cleanroom Construction: How Hybrid Solutions are Changing the Game
August 31st 2025

The Future of Cleanroom Construction: How Hybrid Solutions are Changing the Game

G-CON
Ampoules vaccine from coronavirus with syringe 3d render illustration on white. | Image Credit: © mylisa - © mylisa - stock.adobe.com
August 31st 2025

FDA Approves Moderna’s Updated COVID-19 Vaccines Targeting LP.8.1 Variant

Mastering Antibody-Drug Conjugates
August 31st 2025

Mastering Antibody-Drug Conjugates

BIOVECTRA
Blood sample tube contain with stem cell | Image Credit: © jarun011 - © jarun011 - stock.adobe.com
August 31st 2025

Zemcelpro Stem Cell Therapy Granted EC Conditional Marketing Authorization

Feliza Mirasol
A hand is placing the final wooden block with a green certificate checkmark, symbolizing achievement, quality assurance and completion, against a plain pastel blue background. | Image credit: TimmyTimTim – stock.adobe.com
August 31st 2025

Continued Process Verification Is Critical in Pharmaceutical Manufacturing

Philip Hoersch
© 2025 MJH Life Sciences

All rights reserved.