RAPS

FDA Looking to Improve the Generic Drug Regulatory Process, Wants Industry Input

The US Food and Drug Administration (FDA) plans to hold a public meeting in June 2013 to discuss its progress in advancing regulatory science for generic drug products and solicit feedback on its ...
MarketWatch

2 Day Virtual Drug and Biotech Products FDA Regulatory Compliance Training Course: Practical Applications of the Graded Approach in Manufacturing, Testing, and Quality Control ...

The "FDA Regulatory Compliance for Drug and Biotech Products (Nov 12th - Nov 13th, 2025)" training has been added to ResearchAndMarkets.com's offering. Regulatory Compliance is the level of activity ...
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 ...
National Academies of Sciences%2c Engineering%2c and Medicine

Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years

As noted in Chapter 1, the committee was charged by the Food and Drug Administration (FDA) to review the 510(k) clearance process and answer two principal questions: Does the current 510(k) clearance ...
FiercePharma

FDA emphasizes drug ingredients, production pledges as it debuts PreCheck manufacturing program

Amid an outpouring of industry investments in U.S. drug production, the FDA has launched a new program designed to significantly reduce the complexities involved in setting up domestic manufacturing ...