PharmTech

From Guidance to Operating Model: Preparing CMC and Quality Systems for FDA's Digital-by-Default Oversight

Taken together, these signals operationalize a data-centric oversight model. They also raise a practical question for CMC and ...
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 ...
The National Law Review

FDA Releases Final Guidance on Animal Food Ingredient Consultation Process

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
katc

FDA updates guidelines on coronavirus vaccine

The Food and Drug Administration resisted pressure from the Trump administration on Tuesday by releasing a set of guidelines that could push an emergency use authorization of a coronavirus vaccine ...
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 ...
WCPO Cincinnati

FDA publishes vaccine guidelines opposed by White House

The Food and Drug Administration released updated safety standards Tuesday for makers of COVID-19 vaccines despite efforts by the White House to block them, clearing the way for requirements that are ...
Becker's ASC

FDA Specifies When Existing Devices Need New 510(k) Process

A new FDA draft guidance specifies what kinds of changes in existing medical devices would require new 510(k) submissions, according to an FDA release. For example, changes in device features, such as ...
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 ...
The Baltimore Sun

FDA announces sweeping changes to speed up the drug review process

The Food and Drug Administration has announced some major changes to the review process for drug developers in the United States. It could cut down the time from 10 to 12 months for a review to just ...