FDA Urged to Take “Small Steps” in Developing Final Guidelines for Mobile Medical Apps....

In July 2011, the FDA proposed regulating mobile medical apps as medical devices (see "FDA Issues Long-Awaited Guidance - for Mobile Medical Apps"). FDA has reserved the term "Mobile Medical App" (MMA)...

Lazy IT “Nazis” Thwart iPad Use by Sales Reps

In a recent post, Rich Myer asked "how can pharma avoid the 'IT Nazis'"? Of course, he meant "Nazi" in a "good" sense, akin to the "Soup Nazi" on Seinfeld, the...

Victoza, Januvia, and Other Diabetes Drugs Under FDA Scrutiny: Marketing’s “Ethical Concerns”

"Facing growing evidence that some of America's top-selling diabetes medicines could lead to pancreatic disease, federal regulators on Thursday opened an unusual review of drugs from Merck & Co., Bristol-Myers...

FDA and Sugar: One Lump or Two?

"The U.S. Food and Drug Administration announced that a federal judge has approved a consent decree of permanent injunction against Butterfly Bakery Inc., a bakery based in Clifton, New Jersey, and...

Big Sunshine Law Data

More than half of physicians surveyed by MMIS -- a technology company that supplies data management services to the pharma industry -- did NOT realize that the new Sunshine Law, which...

Are You Demented? There’s an(other) App for That!

"A team of clinicians from Australia and the UK have translated one of the most commonly used dementia screening tools into app form to speed up patient assessment," reports PMLive (here). "The...

OMG, FTC Says “One-Click Rule” OK for Twitter Ads. Will FDA be a Copy...

The Federal Trade Commission (FTC) just released new guidelines to expand its decade-old rules on Web ads to the world of social media and smartphones, reports the Wall Street Journal (guidelines...

Quantified Self-focused Narcissism

South by Southwest (#SXSW) is in full swing in Austin, TX. The conference organizers wouldn't give me a comp press pass, so I am following the health track from afar via...

OPDP Reorganization: Will It De-emphasize DTC Ad Review?

FDA's Office of Prescription Drug Promotion (OPDP) is being re-organized. Instead of separate divisions for consumer promotion (direct-to-consumer or DTC promotion) and professional (HCP) promotion, there will be two divisions focused...

Pharma Dollars for Docs Millionaire Club

Pharma Mints Millionaire Doc: This is America, But Is It Marketing? Dr. Jon W. Draud, the medical director of psychiatric and addiction medicine at two Tennessee hospitals, "earned more than $1 million...

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