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Medical-device companies are finding it harder to land needed approvalsw fromthe U.S. Food and Drug Administratiohn (FDA), which is putting pressurw on companies to provide increasinglg more clinical data andother information, said Mark DuVal, directord and managing partner of DuVal & That’s meant more business for prompting him to hire more attorneys. DuVal Associates specializes in “more intractable approval issues,” DuValp said. “We can go toe-to-toe with push them a bit and debate them a DuVal foundedDuVal & Associatesw five years ago.
In additiob to helping companies clearregulatoryh hurdles, the firm adviseds company officials on ensuring their marketing programs don’t run afoul of FDA guidelines. The firm also helpsa venture capitalists vet young companies before makinfgan investment.
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