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Category Archives: FDA News

April 28, 2017

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Categories: Advocacy, FDA News, Health and Wellness

Dr. Dave’s Med-Sci Matters

Science March (in April) This last Saturday tens of thousands of physicians, scientists and policymakers raised signs and voices at Marches for Science in Washington DC, New York City, Los Angeles, San Diego, Chicago and other cities among some 610...

Dr. Dave’s Med-Sci Matters

Gene therapy success! For the first time, gene therapy has successfully treated a common genetic disorder:  sickle cell disease (SCD), which affects 100,000 people in the United States and millions globally. People with SCD have abnormal hemoglobin due to a...

February 20, 2017

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Categories: FDA News, Healthcare, The Week That Was

The Week That Was: Crises in Communications

Whether your cultural point of reference is Jay-Z or Annie!, we can all agree that last week was a “hard knock life” for orphans…orphan drugs, that is. We saw Marathon hit pause on its launch of Emflaza, the steroid approved...

January 11, 2017

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Categories: Communications, FDA News, Health, Healthcare, Medical Devices and Diagnostics

Dr. Dave’s Med-Sci Matters

Oh nuts! It was hard to miss the coverage this week of new guidelines from the National Institute of Allergies and Disease (NIAID) – published January 5 in J Allergy Clin Immunol – suggesting that early introduction of peanuts into...

June 14, 2016

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Categories: FDA News, Health Policy and Access

Nutrition, Health Care Coverage, Cancer Medication News, FDA and EMA, and More!

New Food Label RecommendationsOn May 27, the FDA issued final changes to the Nutrition Facts Label on foods, the first change in 10 years. The changes are generally are intended to give consumers quicker and easier understanding of the important...

May 24, 2016

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Categories: FDA News, Food and Beverage

New Nutrition Facts Labels Are Coming But Does This Mean You’ll Pay More Attention to What You’re Eating?

We blogged way back in 2014 on the proposed Nutrition Facts Label and since that time there’s been quite a bit of debate on what should and shouldn’t be included on the new labels. Food companies are expected to change...

June 18, 2014

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Categories: Digital and Social Media, FDA News

Social Media Guidance from FDA: Our Take

The U.S. Food and Drug Administration (FDA) yesterday issued draft social media guidance aimed at communicating within character limits and addressing drug misinformation. In each instance, the FDA suggests fair, flexible guidance that will inform social media activity in the...

March 17, 2014

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Categories: FDA News

A Full Serving of Opportunity with the New Nutrition Facts Panel

This piece originally appeared as a guest post on PRWeek.com on March 7, 2014. The First Lady Michelle Obama and the Food and Drug Administration unveiled a new look for the Nutrition Facts Panel, the first significant changes to the...

January 23, 2014

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Categories: Digital and Social Media, FDA News

EXPLAINED: New FDA DRAFT Guidance on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media

On January 13th the Food and Drug Administration (FDA) released DRAFT guidance specific to “Postmarketing Submissions of Interactive Promotional Media.” This long awaited document considers the requirements and responsibility of pharmaceutical companies, their employees, and agents (e.g., KOLs, agencies, contractors)...

November 14, 2012

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Categories: FDA News

FDA Strikes Down on Media Pitch

For those of us in the PR profession who regard the “pitch” for a press release as a single piece of communications, the U.S. Food and Drug Administration has informed us otherwise. The agency regards these as two separate vehicles...