On December 16, 2022, the U.S. Food & Drug Administration (“FDA” or “Agency”) published an important and noteworthy draft guidance document entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a...more
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
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
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
• Nearly a month after Hurricane Maria swept through Puerto Rico, roughly 80 percent of the U.S. territory is still without electrical power. • The island is home to multiple drug manufacturing facilities that are directly...more
On August 31, 2016, the US Food and Drug Administration published “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License...more
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
On October 31, 2013, the U.S. Food and Drug Administration (“FDA”) unveiled its latest steps for preventing and resolving prescription drug shortages. First, the agency announced a proposed rule requiring manufacturers of...more