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"fda"15 articles archived since 1845

Ebola and Priorities in Drug Development

News is rapidly changing regarding Ebola. Even as I've been writing this post, we've gone from "There is no treatment except supportive care" to NIH's Dr.

August 5, 2014 — Judy Stone
Serving size swaps: a research perspective

Serving size swaps: a research perspective

Last month, the Food and Drug Administration proposed changing Nutrition Facts labels to make serving sizes reflect what people actually eat.

March 24, 2014 — Julianne Wyrick

Going gluten-free? Things to consider, part 1: Folate

Last spring, I wrote a blog post for Scientific American's guest blog about gluten sensitivity, a condition in which patients without celiac disease exhibit symptoms, such as bloating or fatigue, that improve with a gluten-free diet.

November 28, 2013 — Julianne Wyrick
Molecules to Medicine: Clinical Trials for Beginners

Molecules to Medicine: Clinical Trials for Beginners

Have you ever wondered about the medicines you take—how they are developed and produced? We'll explore that in "Molecules to Medicine." This new series could be described as "medicine for muggles," intended to take the mystery out of clinical research and drug development and to provide background information so that both patients and physicians can [...]

October 6, 2011 — Judy Stone
Hey FDA, Poop Is Not a Drug

Hey FDA, Poop Is Not a Drug

Imagine if in the 1960s surgeons like Christiaan Barnard or Norman Shumway had had to use the same rules that govern the development and testing of pharmaceutical medications when they were teaching the rest of the world how to transplant hearts from the recently deceased into their patients.

February 19, 2014 — Christine Gorman

New BPA Experiment Finds No Low-Dose Effects

Scientists at the U.S. Food and Drug Administration have found that bisphenol A does not affect the health of rats fed low doses. Other scientists say the study is flawed

February 13, 2014 — Brian Bienkowski and Environmental Health News
Molecules to Medicine: From Test-Tube to Medicine Chest

Molecules to Medicine: From Test-Tube to Medicine Chest

We looked briefly at why drug studies came into being; now let's look at how a drug is developed, from test tube to your tissues. Every government approved drug goes through the same sequence of testing anywhere in the world.

October 19, 2011 — Judy Stone

How Clinical Guidelines Can Fail Both Doctors and Patients

Any confusion over the recent news of cholesterol guidelines in the U.S. is perfectly understandable. On the one hand, the guidelines suggest that nearly half the population should use statins to stave off heart attacks and strokes.

November 22, 2013 — Robert McNutt and Nortin M. Hadler

FDA Was Right To Block 23andMe

A few techno-libertarians are up in arms over the FDA’s letter warning the genetics company 23andme to stop selling its personalized genome services kit.

November 25, 2013 — Christine Gorman

Molecules to Medicine: FDA at a Crossroads—a Tough Place to Be

I took a field trip to the big city last week, to attend the Union of Concerned Scientists' and George Washington University School of Public Health's conference, "FDA at a Crossroads." I have great respect for UCS and their efforts to keep science depoliticized, a topic that I have written and spoken about.

December 7, 2011 — Judy Stone

Lilly's Shocker, or the Post-Marketing Blues

Just last week, I mentioned that Eli Lilly and Company, as a condition of approval for their blockbuster drug, was required to conduct post-marketing studies of Xigris.

November 2, 2011 — Judy Stone

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