The American Journal of Managed Care

Higher-Dose Semaglutide Approved Under New FDA Accelerated Review Process

Accelerated approval of semaglutide 7.2 mg establishes a higher-dose, once-weekly GLP-1 RA option for long-term weight ...
JD Supra

Court gives new life to the post-CRL administrative hearing process, rules that FDA can deny hearing only when evidence is ‘conclusively deficient’

On August 15, 2025, the U.S. Court of Appeals for the D.C. Circuit limited FDA's ability to deny a hearing on the approvability of a new drug application (NDA) based on a lack of “substantial evidence ...
Opinion
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.
Becker's ASC

FDA contemplates changing approval process for software used as a medical device — 4 insights

The FDA is contemplating changing its medical device for software approval process, JD Supra reports. Here’s what you should know. 1. Software as a medical device applies to all software used to ...
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 ...
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 ...
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 ...
Becker's Hospital Review

New FDA office will update drug approval process

The FDA plans to establish the Office of Drug Evaluation Science to improve and modernize the review process for new medications, according to STAT. The new office will help develop a standardized ...

US FDA pushes for new methods to replace animal testing in early drug studies

March 18 (Reuters) - The U.S. Food and Drug Administration on Wednesday issued a draft guidance to help companies reduce ...
WLKY

FDA official plans to change vaccine approval process

A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging that COVID-19 vaccination resulted in the deaths of 10 children.Video above: ...