Topic Archives: Pharmaceutical & Medical Devices

FDA Calls “All Hands on Deck” to Keep Hand Sanitizer Stocked

Last week, the U.S. Food and Drug Administration (FDA) took yet another step to encourage production of basic medical supplies in the battle against COVID-19. On Friday, March 20, FDA published two new guidance documents communicating its policy on the manufacture of certain alcohol-based hand sanitizers. Recognizing the significant supply disruptions for hand sanitizers, and ...›

PREP Act Declaration Emboldens Drug and Device Industry to Innovate in the Face of a Growing Crisis

COVID-19 is, quite literally, putting the medical supply industry to the test. Manufacturers are being pushed to develop novel products like therapies and vaccines to combat the disease as quickly as possible. The Public Readiness and Emergency Preparedness (PREP) Act encourages drug and medical device companies to increase production of existing products currently in short ...›

Committed to Clarity: FDA’s Dedication to Transparency with the End of ASR

On June 21, the Food and Drug Administration (FDA) released a report titled “Statement on agency’s efforts to increase transparency in medical device reporting.” This report describes updates to FDA’s Medical Device Reporting (MDR) Program, namely the conclusion of the Alternative Summary Reporting (ASR) Program. In conjunction with the end of the program, FDA also published ...›

Supreme Court Decides Prescription Drug Preemption Case in Favor of Drug Manufacturer

The United States Supreme Court finally clarified its 11-year-old “clear evidence” standard for pharmaceutical preemption.  In its much-anticipated opinion delivered by Justice Breyer, the Court unanimously reversed the Third Circuit’s holding that questions of pharmaceutical preemption should be decided by juries.  Merck Sharp & Dohme Corp. v. Albrecht et al., No. 17-290, slip op. (U.S. ...›