In another development, 25 states have petitioned to join a lawsuit and defend the EPA’s decision to rescind the climate endangerment finding ...
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 ...
Worcester Telegram on MSNOpinion
Opinion/Guest column: Fastest route to FDA approval not the best
The strength and credibility of the FDA relies on maintaining a clear line between evidence-based, scientific rigor and ...
Incentives to bring vaccines to market are shrinking. Drugmakers are scaling back research investments and cutting jobs.
After the FDA’s first-ever public listening meeting on data-sharing in the cell and gene therapy space, new draft guidance aims to standardize the practice. But recent decisions call into question ...
SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) released draft guidance on how it intends to evaluate ...
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 ...
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 ...
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 ...
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 ...
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