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Medical Devices › Pharmaceutical Industry › Food and Drug Administration Safety and Innovation Act

King & Spalding

FDA Warns Drug & Device Firms Against Delaying & Limiting Facility Inspections in New Draft Guidance

King & Spalding on

On December 16, 2022, the U.S. Food & Drug Administration (“FDA” or “Agency”) published an important and noteworthy draft guidance document entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a...more

Mintz - Health Care Viewpoints

CARES Act Creates and Updates Drug and Medical Device Shortage Requirements

Mintz - Health Care Viewpoints on

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

BakerHostetler

FDA and Pharmacy Weekly Digest - November 2019 #2

BakerHostetler on

President Trump Announces Nomination for Next FDA Commissioner – The president nominated Dr. Stephen Hahn, chief medical executive at the University of Texas MD Anderson Cancer Center, for the position of commissioner of the...more

Butler Snow LLP

Pro Te: Solutio Vol. 11 No. 1 – A Reflection on the First Ten Years

Butler Snow LLP on

It’s hard to believe a decade has passed since we delivered our first edition of Pro Te: Solutio to your door. Those years have brought enormous changes in the world and in our industry. Innovation has driven everything we...more

Mintz - Health Care Viewpoints

FDA Makes More Electronic Submissions Mandatory

Mintz - Health Care Viewpoints on

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

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