FDA Ordered to Submit Quarterly Reports on PMTA Review Process


In his ruling, Judge Grimm stated that the “Plaintiffs have satisfied their burden of showing significant factual changes that support modifying the remedial order at this time.” He also stated that the FDA allowing popular products to remain on the market unreviewed was not consistent with the purpose of the Court’s judgment on the merits earlier in the case.

“Plaintiffs’ proposed reporting requirement will inform the Court and public when FDA expects to take action on those products that account for the largest share of the market. The reporting is tailored to allow the Court to assess FDA’s progress, or lack thereof, towards achieving the goals of the remedial order.”

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