We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.
Results 1 to 5 of 31
Most popular |Most recent

FDA wants to hear from you: Proposed framework for regulating output of digital health tools accompanying prescription drugs as labeling

USA - November 26 2018 On November 20, the Food and Drug Administration (FDA) published a request for comments on a proposed framework for regulating the output of digital...

Sally Gu, Yarmela Pavlovic.

FTC takes on deceptive stem cell therapy claims for blindness cure and autism treatment

USA - November 7 2018 On October 18, the Federal Trade Commission (FTC) announced it settled charges against California-based Regenerative Medical Group, Telehealth Medical...

Lowell Zeta, David Horowitz.

A new normal in the pharmaceutical industry: How to fight back when your competitor can't stop fibbing

USA - October 22 2018 Speaking in September at a discussion hosted by the Alliance for a Stronger FDA, Dr. Janet Woodcock provided some candid insight into FDA's...

Susan M. Cook, Heidi Gertner, Meredith Manning, David M. Fox.

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USA - October 17 2018 On Tuesday, the Food and Drug Administration (FDA or the agency) published a draft guidance document, "Presenting Quantitative Efficacy and Risk...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