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Leah Brasch

FDA Asks Court to Delay Substantial Equivalence Deadline by At Least 10 Months

The U.S. Food & Drug Administration (FDA) has asked a federal court in Maryland to order that FDA’s substantial equivalence deadline should begin no sooner…

FDA Loses Maryland Court Battle, Substantial Equivalence Delay in Jeopardy

There are some court battles the cigar industry would like FDA to win—and it just lost one of them. Earlier today, the U.S. District Court…

Health Groups Sue FDA Over Delay in Deeming Regulations

Seven health groups and five Maryland-based doctors filed a lawsuit today against the U.S. Food & Drug Administration (FDA) and its delay of the deeming…