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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Draft Guidance Covers How to Keep Communications Consistent with FDA Labeling

Jan. 27, 2017 – The FDA issued draft guidance last week that is designed to help medical product  manufacturers understand ...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FDA Issues Draft Guidance on Payor Communications

Jan. 27, 2017 – The FDA recently announced the availability of draft guidance for industry covering manufacturer communications with payors ...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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Coalition and Med Ad News Present Healthcare Podcasts

You can visit to download podcasts on healthcare issues by John Kamp, the Coalition”s Executive Director.

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The 1st is on the defeated but still looming ad tax bill. The 2nd is an overview and analysis of the “New FDA.”

Med Ad News plans to present 3 more podcasts in this series.bayer cipro prostatitis

Study Finds CME Funding Doesn’t Create Bias

A new study by 4 researchers from the Cleveland Clinic showed that industry support of continuing medical education created no bias among participants.

The study acknowledges the controversy surrounding CME funding, then explains how it tested for bias among its participants. It is important to note that no previously published studies have addressed this perceived bias.

Peter Pitts Tells Why FDA DDMAC Letter to Bauman Isn’t a First Amendment Issue

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Much brouhaha about the DDMAC letter sent to Dr. Leslie Bauman about her enthusiastic comments about a yet-to-be-approved anti wrinkle injectable.

At first blush, this seems like regulatory creep and cause for First Amendment agita. But it isn”t. This is not a case of the FDA trying to stifle unregulated speech by an individual without “interest.” Dr. Bauman is a clinical And if you need to relax and unwind a little, what can be better than playing a fun game, which will not set your bank account short? Here on Slotozilla, you can play free slot machines any time of day, with no breaks and no curfews. investigator for the product she”s been touting. That”s “interest” whether the trial sponsor paid her to do so or not. (In this instance, there was no “pay for play.”) In any case, it”s an unambiguous regulatory no-no.

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MM&M Profiles Tom Sullivan, a Forceful Defender of CME

The February issue of MM&M magazine spotlights Policymed.com blogger Tom Sullivan.

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