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

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 ...

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 ...

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 ...

The FDA will expedite the review of nicotine pouches from Philip Morris International (NYSE:PM), Altria (NYSE:MO), Reynolds American, a part of British American Tobacco (NYSE:BTI), and Turning Point ...

The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...

The FDA has released a draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices, according to an FDA news release. The guidance is meant to ...

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: ...

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