The FDA breakthrough therapy program is designed to expedite approval of medical treatments for serious or life-threatening conditions in cases where preliminary tests have suggested significant improvement compared to existing treatments. Upon review, drugs approved as breakthrough therapies generally have less evidence to support them versus FDA approved non-breakthrough drugs and some do not require [...]
The FDA has been approving expensive drugs at record speed even though there may be limited evidence of their effectiveness. Examples include Nuplazid (hallucinations and delusions associated with Parkinson's disease), Uloric (gout), and Folotyn (peripheral T-cell lymphoma). Learn more about this potential quality issue. Could one of these drugs be the next thalidomide? Read [...]
On May 30, 2018, the Right to Try Act was signed into federal law. This legislation gives terminally ill patients direct access to experimental treatments and eliminates Federal Drug Administration (FDA) application requirements. Nearly 40 states have already passed some version of Right to Try (RTT) over the last four years and the federal law [...]
Welcome to the 2nd Edition of the PAHQ Quarterly Newsletter. Read about all the exciting things going on then let us know what you think. Read the full PAHQ Newsletter 2018 Vol 2 - Issue 1
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