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Food and Drug Administration (FDA) › Analytics

Foley & Lardner LLP

FDA: New Guidance for Non-interventional Studies of Drug Safety and Effectiveness

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The U.S. Food and Drug Administration (FDA) has recently issued guidance for sponsors and investigators interested in submitting a non-interventional study, commonly known as an observational study, to contribute evidence of...more

Faegre Drinker Biddle & Reath LLP

FDA Funding Opportunity Announcement: “Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory...

Faegre Drinker Biddle & Reath LLP on

The U.S. Food & Drug Administration (FDA) has released a Funding Opportunity Announcement (FOA) titled “Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

Hogan Lovells on

We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

McDermott Will & Emery

Modernizing FDA’s Data Strategy: Agency Announces March 27 Public Meeting, Requests Written Comments by End of April

McDermott Will & Emery on

On January 7, 2020, the US Food and Drug Administration (FDA) announced that it will hold a public meeting on March 27 to discuss possible Agency-level approaches to modernizing FDA’s data strategy, including approaches to...more

McDermott Will & Emery

FDA Outlines Substantially Revised ‘Possible Approach’ to the Regulation of Laboratory-Developed Tests

McDermott Will & Emery on

On January 13, 2017, the US Food and Drug Administration (FDA) posted a “discussion paper” in which the agency outlines a substantially revised “possible approach” to the oversight of laboratory-developed tests (LDTs). The...more

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