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OPDP Plans Just One Guidance Document for 2017

Feb. 20, 2017 – Although the FDA announced last August that it would issue four advertising-related guidance documents by the ... read more

Kamp: Buckle Up for a Bumpy Ride with Trump

Coalition Commentary by Executive Director John Kamp Feb. 6, 2017 — Fasten your seatbelts and put your tray tables in ... read more

Draft Guidance Covers How to Keep Communications Consistent with FDA Labeling

Jan. 27, 2017 – The FDA issued draft guidance last week that is designed to help medical product  manufacturers understand ... read more

FDA Issues Draft Guidance on Payor Communications

Jan. 27, 2017 – The FDA recently announced the availability of draft guidance for industry covering manufacturer communications with payors ... read more

New Memorandum Spells Out FDA’s First Amendment Position on Off-label Use Promotion

Jan. 20, 2017 – The FDA effectively delayed any prompt action on new guidance covering the promotion of unapproved or ... read more

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Facing the Issues

Here are some important issues that the Coalition has addressed in the past and monitors regularly: