FDA Sensed Firms Bent 98 ASR Rules; Gutman s Group Rewriting Regulation | GenomeWeb

The US Food and Drug Administration’s July 8 letter to the chief of Roche Diagnostics will likely set the tone for the way the agency oversees analyte specific reagents in the future, according to industry experts.

Additionally, in a separate resolution that will broadly impact many molecular diagnostics firms, the agency has decided to rewrite the original ASR regulation written in 1997 and enacted in November 1998, SNPtech Reporter has learned.

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