Regulatory Affairs Professionals Society

FDA review finds growing use of process models to support drug submissions

Drug manufacturing process models represent a "growing area" of scientific development and are increasingly being utilized in ...
Yahoo Finance

Biopharmaceutical Manufacturing Process Validation: Understand FDA Guidance and EU Guidelines (Nov 17th - Nov 18th, 2025)

Dublin, Oct. 28, 2025 (GLOBE NEWSWIRE) -- The "Biopharmaceutical Manufacturing Process Validation (Nov 17th - Nov 18th, 2025)" training has been added to ResearchAndMarkets.com's offering. This ...
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 ...
JD Supra

New FDA approval process promotes development of rare disease gene therapies

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...
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 ...
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 ...
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 ...
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

The US Food and Drug Administration (FDA), through its Center for Devices and Radiological Health (CDRH), regulates medical devices and radiation-emitting products. 1 The 510(k) clearance process, ...