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FinCEN Warns of Scams Relating to PPE and Other Medical Goods During COVID-19 Pandemic

In struggling to address the evolving COVID-19 pandemic, the United States and many other countries continue to face major shortages of Personal Protective Equipment (PPE), such as N95 masks, gowns and other vital materials...more

FDA Issues Statement on Cannabis Regulation and Announces Public Hearing

On April 2, 2019, FDA outlined new steps to advance review of potential regulatory pathways for cannabis-containing and cannabis-derived products. In a statement issued by Commissioner Scott Gottlieb, released in conjunction...more

FDA Issues Warning Letter Regarding Unapproved Stem Cell Products

The U.S. Food and Drug Administration (FDA) issued a statement on Dec. 20, 2018, once again putting stem cell companies on notice about its intention to crack down on the marketing of unapproved stem cell products, and...more

FDA Commissioner Speaks Out on Compliance and Enforcement

On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more

FDA Releases New Enforcement Policy for OTC Sunscreen Drug Products Marketed Without an Approved Application

In May 2018, the Food & Drug Administration (FDA) released a new enforcement policy for over-the-counter (OTC) sunscreen drug products marketed without an approved application. While sunscreens have been commercially...more

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