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Food and Drug Administration (FDA) › Arbitrary and Capricious

Manatt, Phelps & Phillips, LLP

Laboratory Association Sues FDA Over its Recent Laboratory-Developed Test Final Rule

Manatt, Phelps & Phillips, LLP on

On May 29, the American Clinical Laboratory Association (ACLA) sued the Food and Drug Administration (FDA) in an effort to vacate its recent final rule that will gradually phase out FDA’s long-standing policy of enforcement...more

Troutman Pepper

Clinical Diagnosis of FDA's Clinical Investigation Exclusivity Standard? Unreasonable

Troutman Pepper on

For drug innovators, particularly those focusing on repurposing drugs for new indications and developing drugs that are not considered new chemical entities, understanding the scope of the clinical investigation exclusivity...more

McDermott Will & Emery

Arm’s Length Royalty Rates Save Medtronic from $1.36 Billion Tax Deficiency

McDermott Will & Emery on

Addressing whether certain intercompany technology license agreements were negotiated at arm’s length, the US Tax Court rejected the Internal Revenue Service’s (IRS’s) alleged $1.36 billion tax deficiency and determined that...more

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