News & Analysis as of

Abbreviated New Drug Application (ANDA) Food and Drug Administration Safety and Innovation Act

Foley Hoag LLP

FDA Issues Draft Guidance Recommending "Race and Ethnicity Diversity" Plans for Clinical Trial Sponsors

Foley Hoag LLP on

Key Takeaways: The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials. FDA’s recommendations come as part of increasing interest in ensuring clinical...more

Mintz - Health Care Viewpoints

CARES Act Creates and Updates Drug and Medical Device Shortage Requirements

In response to the COVID-19 pandemic, the Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed into law on March 25, 2020. In addition to the $2 trillion made available for medical countermeasure development,...more

Hogan Lovells

There'll Be Some Changes Made: President Signs Prescription Drug and Biologic User Fee Reauthorization Act

Hogan Lovells on

On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more

Mintz - Health Care Viewpoints

FDA Makes More Electronic Submissions Mandatory

In recent months, the FDA has been pushing forward in its efforts to require that more information from regulated industry be submitted electronically. The move to electronic submissions should create a more efficient and...more

4 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide