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FDA Seeks Patient Insight on Certain Diseases

The FDA has announced that they will further meet with patients suffering from certain diseases.  This will the be second set of meetings planned by the FDA.  The meetings are meant to provide a more comprehensive look at the drug approval process by focusing on the patients these drugs will treat.  Patients with conditions and diseases for which there are few treatment options available believe that the FDA is too strict when it comes to approving drugs.  Certain drugs may have potentially helped some patients that had no other option.

The 16 new disease areas proposed include: achondroplasia, alopecia areta, autism, autoimmune disorders treated with immune globulins, depression, diabetic foot infection, hereditary angiodema, melanoma, neurologic disorders treated with immune globulins, nontuberculous mycobacterial infections, ovarian cancer, patients who have received an organ transplant, primary humoral immune deficiencies, pruritis, sarcopenia, and thrombotic disorders.

Read more about the proposed meetings here

J. Lewis Research, Inc.

J. Lewis Research, Inc.

We are a unique research company in Salt Lake City with over 25 years of experience conducting clinical trials for the pharmaceutical industry, specializing in Phase II, III and IV clinical trials.