–Shifting the burden of proof from preapproval to postapproval. The new FDA commissioner Scott Gottlieb is quietly and persistently revamping the FDA to make it easier for drug and device companies to get their products on the market. The news, which is being welcomed by industry, also almost certainly means that more people will be…
Cardiac Stem Cell Therapies May Get Boost From New FDA
September 14, 2017 by 1 Comment
–The FDA may not require companies to prove that stem cell therapies are safe and effective prior to approval. Cardiac stem cell therapy could gain FDA approval far earlier than most people expect, despite the fact that these therapies have consistently failed to produce any convincing evidence of safety and efficacy. Under the old FDA…
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