Stacy Cline Amin spoke to Bloomberg Law about the U.S. Food and Drug Administration (FDA)’s proposed rule that would hand the agency explicit authority to regulate lab-developed tests (LDTs), which could require the products to face additional rigorous review before being marketed.
“The litigation over the LDTs rule has the potential to be the most significant litigation FDA has seen since the legal fight over the regulation of tobacco products in the ‘90s,” said Stacy. “The lab industry views this as an existential threat and has demonstrated in the past its willingness to devote tremendous resources to challenging the agency’s attempt to assert greater regulatory oversight.”
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