Article

FDA Final Rule

Author(s):

BioPharm International Editors

FDA final rule requiring foreign drug and biologics manufacturers to register their operations and products. Takes effect 11 Feb 2002

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
How the 15% US-EU Tariff Cap Affects Bio/pharma
Dave Miller, PhD, Chief Scientific Officer, AustinPx
Dave Miller, PhD, Chief Scientific Officer, AustinPx
Related Content
PRAGUE, CZECHIA - NOVEMBER 1, 2019: Astellas logo in front of their main office for Prague. Astellas Pharma is a Japanese Pharmaceutical company spread worldwide | Image Credit: © Jerome - stock.adobe.com
August 22nd 2025

Astellas and Pfizer Bladder Cancer Therapy Recommended by UK’s NICE

Patrick Lavery
The Future of Cleanroom Construction: How Hybrid Solutions are Changing the Game
August 22nd 2025

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

G-CON
Bio/Pharma's Response to Tariff and Trade Policy
August 22nd 2025

Bio/Pharma's Response to Tariff and Trade Policy: Survey Results

Christopher Cole
Mastering Antibody-Drug Conjugates
August 22nd 2025

Mastering Antibody-Drug Conjugates

BIOVECTRA
The front of the REGENXBIO facility in Rockville, Montgomery County, Maryland. REGENXBIO is a biotechnology company researching Adeno-Associate Virus (AAV) gene therapy | Image Credit: © MJ Kerr - stock.adobe.com
August 22nd 2025

FDA Extends Review Period for REGENXBIO Hunter Syndrome Treatment

Patrick Lavery
Lung cancer, 3D illustration and photo under microscope. Histopathology light micrograph of small cell lung cancer | Image Credit: © Dr_Microbe - © Dr_Microbe - stock.adobe.com
August 22nd 2025

Merck and Daiichi Sankyo’s I-DXd Earns FDA Breakthrough Therapy Status in Small Cell Lung Cancer

Feliza Mirasol
© 2025 MJH Life Sciences

All rights reserved.