News & Analysis as of

Food and Drug Administration (FDA) FDA Approval Over The Counter Drugs (OTC)

American Conference Institute (ACI)

[Event] 42nd FDA Boot Camp - March 13th - 14th, New York, NY

ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Stocking Naloxone in the Workplace: What Employers Need to Consider

It is well known that opioid overdoses have occurred at epidemic levels in the United States for years. According to the U.S. Centers for Disease Control and Prevention (CDC), opioid overdose deaths have increased from 21,089...more

Sheppard Mullin Richter & Hampton LLP

Withdrawal of Drug Approval Highlights Risk of Accelerated Approval Pathway

On April 5, 2023, the U.S. Food and Drug Administration (“FDA”) announced its decision to withdraw the approval of Makena® hydroxyprogesterone caproate injection (“Makena”) – a drug that was approved in 2011 to reduce the...more

Knobbe Martens

FDA Approval for Novel Medical Devices Remains a High Priority, Despite COVID-19

Knobbe Martens on

In addition to its significant efforts to fast track the approval of COVID-19 related devices, the FDA’s Center for Devices and Radiological Health (CDRH) has also maintained its high priority focus on supporting innovation...more

Morgan Lewis

FDA’s End-of-Year Gifts: COVID-19 Diagnostic Tests and Collection Devices for Home Use

Morgan Lewis on

The Food and Drug Administration (FDA or the Agency) spent the remaining weeks of 2020 issuing Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC...more

Morgan Lewis

FDA Issues New Temporary Policy for the Manufacture of Alcohol for Hand Sanitizer Products

Morgan Lewis on

In light of the hand sanitizer shortage during the coronavirus (COVID-19) pandemic, many manufacturers are seeking alternative sources of alcohol for incorporation into their hand sanitizer products. The need for alcohol has...more

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