News & Analysis as of

Final Rules Federal Food Drug and Cosmetic Act (FFDCA) Trump Administration

Mintz - Health Care Viewpoints

A Texas Federal Court Sides with Laboratories, But There May Be Unintended Consequences for FDA

The obvious result of the legal shootout between the U.S. Food & Drug Administration (FDA) and clinical laboratory trade associations, the American Clinical Laboratory Association and the Association for Molecular Pathology,...more

Sheppard Mullin Richter & Hampton LLP

LDT Final Rule Series: Part 3 – Legal Challenges

This year, we have seen several monumental events that already are, or potentially could be, pivotal to the future of the Laboratory Developed Test (“LDT”) industry – first, the issuance of the U.S. Food & Drug Administration...more

Robinson+Cole Health Law Diagnosis

Federal Judge Vacates Final Rule on Drug Pricing Transparency in Consumer Advertising

In a Memorandum Opinion, Judge Amit P. Mehta, of the U.S. District Court for the District of Columbia, vacated a U.S. Department of Health and Human Services (HHS) Final Rule, just days before its July 9 effective date. The...more

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