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FDA pushes "consumer-friendly" presentation of quantitative data in DTC promotions

USA - October 17 2018 On Tuesday, the Food and Drug Administration (FDA or the agency) published a draft guidance document, "Presenting Quantitative Efficacy and Risk...

Carlo Felizardo, Cailin Lechner, Jane Kalinina, Meredith Manning.

FDA guidances promote greater communication to payors about medical product value, clarify CFL communications

USA - June 14 2018 On June 12 the U.S. Food and Drug Administration (FDA or the Agency) finalized two guidance documents regarding the types of information that drug and...

Jodi Scott, Arthur E. Kim, Heidi Gertner, Jennifer Agraz Henderson, Danielle C. Humphrey, Suzanne Levy Friedman, Jane Kalinina, Yetunde Oni, Meredith Manning.

Obtaining FDA clearance or approval of digital health products

USA - March 14 2018 Many digital health products are regulated by the U.S. Food and Drug Administration (FDA) as medical devices or, when used in conjunction with a...

Yarmela Pavlovic.

FDA Clarifies and Expands Eligibility for RMAT Designation for Gene Therapies

USA - November 22 2017 On November 16, in the context of announcing a comprehensive regenerative medicine policy framework (discussed here), FDA released a draft guidance...

David Horowitz, David M. Fox, Mike Druckman.

Follow the Money: FDA Issues New Procedures for Evaluating Financial Ties Between Application Sponsors and Clinical Investigators

USA - July 5 2017 In a potential sign of renewed interest in financial ties between industry and clinical investigators, the Food and Drug Administration’s (FDA)...

Heidi Gertner, Katelyn A. Ruiz, Robert Church.