BioSpace

CDMOs Pin Hopes for Accelerating Uptake at New US Sites on FDA’s PreCheck Program

The initiative could tackle the first-mover disadvantage some CDMOs believe deters early customers, but leaders at companies ...
Healio

Q&A: FDA update to biosimilar approval process may reduce time, cost of development

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
BioSpace

AbbVie, Amgen, Lilly Lead Calls for FDA To Update Post-Approval Change Rules

Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...
Reporter-Herald

Letters: FDA regulatory process

With the 2024 election in the rearview mirror and the dust settling nationally and here in the state, we must make clear that in Colorado we believe in good governance and take fulfilling our ...
JD Supra

AI’s Expanded Role in the Life Sciences Regulatory Review Process: Key Developments in U.S. and EU

The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025.
pharmaphorum

FDA removes barriers to cell, gene therapy development

"Regulatory flexibility must be tailored for cell and gene therapies," commented FDA Commissioner Marty Makary. "These are ...
Yahoo

Abolish the FDA (opinion)

It takes 10–15 years and hundreds of millions of dollars for a pharmaceutical company to navigate the Food and Drug Administration (FDA) regulatory process and bring a new drug to market. Many ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
Reason

Abolish the FDA

It takes 10–15 years and hundreds of millions of dollars for a pharmaceutical company to navigate the Food and Drug Administration (FDA) regulatory process and bring a new drug to market. Many ...