FDA Reaches 70-Day Review Period for Medical Device Pre-Submission Meeting Requests Under MDUFA V

As Diseases Spread and Trust in the FDA Crumbles, Its Leaders Are Obsessed with an MRI Abnormality in 1 in 61,500 Males Ages 12-24

Our medical establishment told people to "Stop Trusting the Public Health Establishment". Now, almost no one trusts our medical establishment. The post As Diseases Spread and Trust in the FDA Crumbles, Its Leaders Are Obsessed with an MRI Abnormality in 1 in 61,500 Males Ages 12-24 first appeared on Science-Based Medicine.

FDA Reaches 70-Day Review Period for Medical Device Pre-Submission Meeting Requests Under MDUFA V

The U.S. Food and Drug Administration (FDA) has reached […] The post FDA Reaches 70-Day Review Period for Medical Device Pre-Submission Meeting Requests Under MDUFA V first appeared on GeneOnline News. The post FDA Reaches 70-Day Review Period for Medical Device Pre-Submission Meeting Requests Under MDUFA V appeared first on GeneOnline News.

To Meet or Not to Meet: Day 70 and Counting

Recent communications from CDRH indicate that impacts to resources from Reductions-In-Force are causing some Offices in CDRH to delay granting a request for a pre-submission (or Q-Submission) meeti…