April 27, 2016. Testimony at Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) regarding the definition of treatment resistant depression, the use of the definition in clinic and research, and research concerning treatment resistant depression.
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Testimony at FDA on Eteplirsen for Duchenne Muscular Dystrophy
April 25, 2016. U.S. law requires evidence of safety and effectiveness. The burden of proof lies with Sarepta. If this drug actually works, then Sarepta has failed itself, the patients, and their families, by not conducting a better study that could provide convincing evidence showing that it works.
Read More »Letter to House Appropriation Committee Members Regarding FDA’s Proposed Rule on the Labeling of Generic Drugs
April 18, 2016. The National Center for Health Research strongly urges you to remove the anti-consumer language from the House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for fiscal year 2017. The language (Section 747) was added at the 11th hour and it would prevent the FDA from finalizing its proposed rule on generic drugs labeling.
Read More »NCHR Testimony at 2016 FDA Meeting on Rociletinib
April 12, 2016. NCHR realizes that there is currently an unmet need for a drug to treat patients whose NSCLC has become resistant to first line TKI therapies via the T790M mutation. However, this does not warrant the approval of yet another drug that will not significantly improve outcomes for these patients. Fortunately, there is hope on the horizon, because the preliminary results for osimertinib for the same patients appears to be much more effective with fewer serious side effects.
Read More »NCHR Testimony at FDA on Pimavanserin (Nuplazid) for Parkinson’s Patients with Psychosis
March 29, 2016. Because of concerns over the limited efficacy, the test used, and the high incidence of adverse events, NCHR urges FDA to not support the approval of pimavanserin [Nuplazid].
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