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Changes Coming to How FDA Regulates Cosmetics

The FDA announced on Feb. 28, 2023, it will move cosmetics regulation out of the CFSAN and into the OCS. The move stems from the FDA's broader initiative to reorganize food safety regulation and oversight, as well as allow...more

PREP Act: Liability Protection Is Available During COVID-19 Pandemic

Issues relating to liability for pharmaceutical, personal protective equipment (PPE) and diagnostic test businesses as well as for physicians and healthcare personnel in the coronavirus (COVID-19) context remains a salient...more

FDA Updates Policy for Antibody Tests for COVID-19: New Requirements for Manufacturers

In response to the COVID-19 pandemic and the need for more diagnostic testing, the U.S. Food and Drug Administration (FDA) has developed several pathways for manufacturers and developers of COVID-19 diagnostic tests to...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

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