Publication Detail

Missing The Point (Of Care): FDA Misreading Of CLIA Waiver Law Undermines Cost-Effective Health Testing
Topic: Health Care
By James A. Boiani, a senior associate in the Washington, D.C. office of the law firm Epstein Becker & Green P.C., and Stuart M. Gerson, a partner with Epstein Becker & Green P.C.
Legal Backgrounder, October 11, 2013, 4 pages
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Publication Summary:

Publication Summary 


FDA’s misinterpretation of a single word in the statute establishing standards for granting waivers from extensive regulatory requirements is chilling the use of cost-effective health tests in the U.S.


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