CSNews

FDA Updates Draft Guidance on Flavored Vapor Applications

The U.S. Food and Drug Administration (FDA) released draft guidance on how it intends to evaluate premarket tobacco product applications (PMTAs) for flavore ...
PhillyVoiceOpinion

FDA's abrupt flip‑flop on Moderna's mRNA flu shot highlights growing risks to drugmakers of investing in vaccines

Incentives to bring vaccines to market are shrinking. Drugmakers are scaling back research investments and cutting jobs.
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 ...
Healio

FDA provides new approval process for rare disease therapies without large clinical trials

Please provide your email address to receive an email when new articles are posted on . The pathway aims to streamline approval for individualized treatments for rare and ultra-rare diseases. An ...
JD Supra

FDA’s Rare Disease Evidence Principles Process Provides Guidance for Applications Supported by a Single Pivotal Trial

On September 3, 2025, the US Food and Drug Administration (FDA) announced a new process to support the development of drugs intended to treat rare genetic diseases. The Rare Disease Evidence ...
Opinion
BioSpaceOpinion

Opinion: Rare Disease Patients Can’t Wait for Regulatory Process

The U.S. Senate has a plan to improve drug development for rare disease patients. The exit of controversial CBER chief Vinay Prasad will help clear the path.
Benzinga.com

FDA Outlines Process To Speed Up Rare Disease Therapy Approvals

The U.S. Food and Drug Administration on Thursday introduced the Rare Disease Evidence Principles (RDEP) to provide greater speed and predictability in the review of therapies intended to treat rare ...
MobiHealthNews

How the FDA process is biased against new technology

As FDA itself observes, “devices of a new type that FDA has not previously classified … are ‘automatically’ or ‘statutorily’ classified into class III…, regardless of the level of risk they pose.” To ...
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 ...
Convenience Store News

FDA Streamlines PMTA Process With Improved Web-Based Options

CTP Portal Next Generation also accepts Substantial Equivalence submissions. Step-by-step instructions on completing the forms; A more user-friendly interface that helps guide applicants through the ...
RealClearPolitics

FDA Commissioner Marty Makary: Starting Process To Schedule "7-Hydroxymitragynine" Kratom Extract As Dangerous, Illegal Opioid

FDA Commissioner Marty Makary said at a press conference Tuesday that the federal government is beginning to process to classify 7-Hydroxymitragynine (7-OH-MIT), a kratom extract sold at gas stations ...