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Public Health › Food and Drug Administration (FDA) › Laboratory Developed Tests

Venable LLP

The End of FDA’s LDT Rule, Trump Administration’s Regulatory Agenda Released, an Analysis of HHS Workforce Reductions Raises...

Venable LLP on

Earlier this month, the Office of Information and Regulatory Affairs (OIRA) updated its list of rules pending review under Executive Order 12866 to include FDA's request to rescind its controversial Laboratory Develop Test...more

Akin Gump Strauss Hauer & Feld LLP

FDA’s Proposed Rule on Laboratory Developed Tests: One Small Change to Regulatory Language That Would Mark a Giant Leap in Lab...

Akin Gump Strauss Hauer & Feld LLP on

On October 3rd, the Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). Last year, Congress failed to pass the Verifying Accurate,...more

Mintz - Health Care Viewpoints

FDA in 2020: What a Year!

Mintz - Health Care Viewpoints on

What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was...more

K&L Gates LLP

COVID-19: K&L Gates Triage: FDA Facilitates Diagnostic Testing and Heightens Public Safety Efforts Amid Outbreak

K&L Gates LLP on

In this week’s episode, Kenneth Kennedy discusses several of FDA’s strategies for helping stakeholders in the drug and medical device industry support health care providers in their fight against the COVID-19 outbreak. In...more

Hogan Lovells

FDA Issues Laboratory Accreditation Proposed Rule Required Under FSMA

Hogan Lovells on

The U.S. Food and Drug Administration (“FDA”) recently issued a proposed rule entitled “Laboratory Accreditation for Analyses of Foods” (“Proposed Rule”), which was mandated by the FDA Food Safety Modernization Act (FSMA)....more

Sheppard Mullin Richter & Hampton LLP

FDA Issues Warning Letter to Lab Marketing Three Laboratory-Developed Tests

Sheppard Mullin Richter & Hampton LLP on

In an April 4, 2019 Press Release, the U.S. Food and Drug Administration (FDA) announced its issuance of a Warning Letter to Inova Genomics Laboratory (Inova) in Virginia for marketing genetic tests for predicting medication...more

Bass, Berry & Sims PLC

FDA Warns Against Direct-to-Consumer Lab Developed Tests

Bass, Berry & Sims PLC on

Despite it being a continual topic of discussion, the Food and Drug Administration (FDA) enforcement in the realm of laboratory developed tests (LDTs) has been relatively quiet in recent years. That is, until earlier this...more

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