Category Archives: Clinical Trials

FDA and Patient Involvement

“I am a cancer survivor, I was treated for cancer during my last tour at FDA, so I k now the importance of what American medicine does — and what the FDA does — for every one of us.” Scott … Continue reading

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NIH Clinical Trials and You

For a long time, I have thought that clinical trial information was too clinical to be of much use for patients who might be considering entering one.  The information available was either in the form of searchable data bases, text … Continue reading

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Clinical Trials and Search

You are sitting in the doctor’s office on that crinkly paper that pops every time you move. Your physician is leaning against a table and has just uttered some words that were a diagnosis.  It is a serious diagnosis.  For … Continue reading

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Clinical Trials and Social Media – Part 1 in an Intermittent Series

Last week Brian Reid wrote an excellent piece on the Common Sense blog entitled “The 5 Consequences of the Lack of FDA Social Media Guidance“.  He got off to a great start, but I actually think there are many more … Continue reading

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Adolor Corp. Gets Approvable Letter

Today Adolor Corp. announced receipt of an approvable letter from the FDA requesting 12-month safety data that includes an analysis of any cardiovascular related adverse events.  The application was for Entereg, indicated for the management of postoperative ileus.  Share this:

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