RAPS

FDA Guidance Explains Nuances of Making Changes to Generic Drug Submissions

FDA Guidance Explains Nuances of Making Changes to Generic Drug Submissions A new draft guidance document published yesterday by the US Food and Drug Administration (FDA) aims to clarify what sponsors ...
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 ...
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 ...
Regulatory Affairs Professionals Society

FDA finalizes guidance on CMC flexibilities for cell and gene therapies

The US Food and Drug Administration (FDA) has released a final guidance document with immediate effect advising sponsors on ...
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 ...
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 ...
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FDA To Streamline Approval Process For Generic Biological Drugs

The U.S. Food and Drug Administration (FDA) announced on Wednesday (October 29) a plan to streamline the approval process for biosimilars, which are generic versions of complex biological drugs. These ...
JD Supra

Our Takeaways from the 2026 FDLI Annual Conference

Annual Conference is in the books, and the Food and Drug Administration’s (FDA) messaging at the 2026 edition blended ...
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 ...
JD Supra

Before it hits the shelf: FDA reprocesses the new dietary ingredient notification process

On June 11, 2025, the US Food and Drug Administration (FDA) released educational materials to broaden dietary supplement manufacturers’ and distributors’ awareness and understanding of the FDA’s new ...
The National Law Review

Digital Health Policy- FDA Relaxes Restrictions over Wearables and AI Decision Making Tools in Two New 2026 Guidances

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 ...