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Prescription Drugs › Over The Counter Drugs (OTC) › Enforcement Actions

Sheppard Mullin Richter & Hampton LLP

Reminder: FDA Does, In Fact, Review DOF

Sheppard Mullin Richter & Hampton LLP on

When was the last time you thought about “data on file” (“DOF”)? Probably not recently, but last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted an untitled letter (the...more

American Conference Institute (ACI)

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

American Conference Institute (ACI) on

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

Searcy Denney Scarola Barnhart & Shipley

FDA Reports Sterilization Issues in EzriCare Factory: Bacterial Contamination in Artificial Tears Products

Searcy Denney Scarola Barnhart & Shipley on

Earlier this year, the US Center for Disease Control and Prevention (“CDC”) spotted an outbreak of a rare bacterial infection in 11 (now 16) different states, associated with multiple different infection types, particularly...more

Console and Associates, P.C.

Some OTC Supplements Contain Tadalafil, According to the FDA

Console and Associates, P.C. on

In recent months, the Food and Drug Administration (FDA) announced several recalls related to natural supplements that were found to contain tadalafil and its analogs, the active ingredients in Viagra and Cialis. In its...more

Mintz - Health Care Viewpoints

FDA in 2020: What a Year! (Part 3 of 3)

Mintz - Health Care Viewpoints on

In addition to the incredible work of agency scientists and reviewers to get the first COVID-19 vaccines authorized for emergency use in December (as we covered in Part 2 of our year-end post), the Food and Drug...more

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