2 Day Virtual FDA and EU Annex 15 Process Validation Guidance & Requirements Training ...

The FDA Process Validation training highlights opportunities in enhancing comprehension of constant process verification aligned with lifecycle concepts. It addresses early R&D phases through ...

FDA set to pilot test real-time tracking of clinical trials

The Food and Drug Administration (FDA) is set to pilot test real-time clinical trials in the hopes of expediting results and ...

Food and Drug Administration (FDA): What It Is and Does

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.
MobiHealthNews

Q&A: A doctor's opinion on the FDA AI certification process

According to the Food and Drug Administration (FDA), the traditional paradigm of medical device regulation was not designed for adaptive artificial intelligence and machine learning technologies. As a ...

How some food additives bypass the FDA review process

Today, the vast majority of new food additives, most of them industrially produced, make it to market via the GRAS pathway ...
Business Wire

Drug Farm Announces FDA Acceptance of DF-003 into Rare Disease Evidence Principles Process ...

ALBANY, N.Y. & SHANGHAI--(BUSINESS WIRE)--Drug Farm today announced that the U.S. Food and Drug Administration (U.S. Food and Drug Administration, FDA) has accepted DF-003, the company’s ...
RAPS

FDA Kicks off Reauthorization Process for PDUFA

The US Food and Drug Administration (FDA) has announced the start of the next reauthorization process for the Prescription Drug User Fee Act (PDUFA), a major framework under which most new drug ...
dvm360

FDA is hosting public meetings to discuss drug user fee legislation

Officials with the FDA have announced virtual public meetings to discuss the Animal Drug User Fee Act (ADUFA) and Animal ...
来自MSN

FDA’s commissioner vouchers prompt questions about award process

In June 2025, the US Food and Drug Administration (FDA) announced the Commissioner's National Priority Voucher (CNPV) pilot programme. The regulatory framework allows biotechs and pharma companies who ...

FDA to expedite review process for psychedelic drugs following executive order

The FDA plans to expedite the review process for three psychedelic drugs aimed at treating mental health issues, following ...
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 ...