The FDA has opened the door to the use of Bayesian statistical methods in clinical trials. The worry: Introducing ...

Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...

Opinion: The Food and Drug Administration's updated guidance on wellness devices will help ensure that products are appropriately positioned in the market—while staying away from unsupported, ...

The Food and Drug Administration (FDA) has backtracked its initial decision last week of refusing to review Moderna’s mRNA ...

Instead of making life easier for medical device companies, the FDA’s new wearables guidance makes the market more complex.

Many Medtech startups view FDA and similar regulatory bodies as a roadblock. Something that is there to get in their way, slow them down, and cost them a fortune. Smart companies see regulations as an ...

(I would like to thank Dr. Deepak Ayyagari of Sharp Laboratories of America and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s ...

An analysis of internal Food and Drug Administration documents by researchers at the Johns Hopkins Bloomberg School of Public Health finds that the agency generally followed cautious and ...