CDRH

Unpacking Averages: Connecting Published Clinical Trials with FDA Drug Approvals

By Bradley Merrill Thompson on March 1, 2022

I recommend against relying on any data I provide in today’s post. I hope the data are at least somewhat accurate. But they are not nearly as accurate as they should be, or as they could be, if FDA just released a key bit of information they have been promising to share for years.

One of the ways data scientists can provide insights is by grafting together data from different sources that paint a picture not seen elsewhere. What I want to do is join the clinical trial data at www.clinicaltrials.gov with the data maintained by FDA of approved drugs, called drugs@FDA. But I can’t, at least not with much accuracy.…

Continue Reading Unpacking Averages: Connecting Published Clinical Trials with FDA Drug Approvals

The Role of Patient Preference in Medical Device Evaluation

By Bonnie Odom on May 23, 2019

Posted in FDA, Health Information Technology, Medical Device

When we think about the top players in the medical device development space, we often see device company sponsors, clinicians, scientists, and FDA regulators as the ones driving the process. But what about the patient perspective? Does that get factored in?

On May 3, 2019, FDA established a docket to collect public input on a…

FDA Continues Its De-Regulatory Trend with the Release of the Wellness Guidance

By Kim Tyrrell-Knott on January 22, 2015

Posted in FDA

FDA published the long awaited draft guidance on wellness products last Friday. The guidance is a positive step forward for industry in that it proposes that certain general wellness products will not be subject to FDA regulation.

The draft guidance clarifies that FDA does not intend to enforce its regulations against products that are “low…

CDER May Need to Catch Up to CDRH in Terms of Proposed Guidance List

By Shilpa Prem on January 14, 2015

Posted in FDA

Last week both CDER and CDRH released a list of guidance documents they intend to develop or finalize over the next year. However, it is interesting to note that the approach and information provided by each FDA center diverged significantly. CDRH provided details as to the priority of guidances they plan on developing, offered specific…

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CDRH

Unpacking Averages: Connecting Published Clinical Trials with FDA Drug Approvals

The Role of Patient Preference in Medical Device Evaluation

FDA Continues Its De-Regulatory Trend with the Release of the Wellness Guidance

CDER May Need to Catch Up to CDRH in Terms of Proposed Guidance List

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