April 6, 2020: We support FDA’s decision to conduct a comprehensive evaluation of opioid prescribers’ knowledge, attitudes, perceptions, experiences and behaviors related to Abuse Deterrent Formulations (ADF) and agree with the FDA that new language is needed to better describe and explain ADF.
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FDA Grants Experimental Coronavirus Drug Benefits For Rare Disease Treatments
NPR, March 25, 2020. FDA gives possible new drug to treat coronavirus orphan drug status, despite the fact that more than 200,000 people will ultimately get coronavirus.
Read More »New FDA Virus-Test Policy Could Boost Availability, But Reduce Reliability
Wall Street Journal, March 17, 2020. The new FDA virus-test policy could help east shortage of tests, but may lead to inaccurate results.
Read More »NCHR’s comments on FDA’s Draft Guidance for Industry on Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
March, 19, 2020: The FDA’s draft guidance describes circumstances under which exceptions can be made to the requirement of two adequately controlled clinical trials. Although the law allows these exceptions under certain circumstances, we have concerns over the frequency with which these exceptions are made.
Read More »NCHR’s Comments on Cyramza for Metastatic Lung Cancer at FDA Oncologic Drugs Advisory Committee Meeting
February 26, 2020. We oppose approval of this indication of Cyramza without evidence that it improves overall survival enough to outweigh the risk for adverse events and reduced quality of life.
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