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Laboratories Manufacturers

Holland & Knight LLP

FDA Enforcement Against Dental Lab Could Have Broader Implications

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The U.S. Food and Drug Administration (FDA) recently published a warning letter (Warning Letter) targeting a dental laboratory after a lengthy inspection found that the dental laboratory's operations, which offer...more

Robinson+Cole Health Law Diagnosis

FDA Sued Over Laboratory Developed Tests Final Rule

The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed Tests (LDTs). The Final Rule requires laboratories to adhere to the same preapproval and...more

Perkins Coie

Oregon Finalizes New Regulations To Implement Psilocybin Services Act

Perkins Coie on

Oregon became the first state to offer controlled use of psilocybin to the public on January 1, 2023. Psilocybin is a Schedule I psychoactive substance that is illegal at the federal level. Notwithstanding this federal...more

Fox Rothschild LLP

NJ Cannabis Webinar Provides Key Insights on Licensing Process, Equity, Municipalities

Fox Rothschild LLP on

The much-anticipated October 13 Recreational Cannabis Statewide Information Webinar presented by New Jersey’s Cannabis Regulatory Commission (CRC) provided critical information on the state’s adult-use cannabis program,...more

Holland & Knight LLP

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

Holland & Knight LLP on

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

McDermott Will & Schulte

FDA Offers Laboratories, Manufacturers New Flexibility to Expedite COVID-19 Testing

On March 16, 2020, the US Food and Drug Administration (FDA) announced several initiatives intended to further increase access to validated COVID-19 testing. This alert addresses key components of the announcement, which...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2017

Bass, Berry & Sims PLC on

A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more

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