Publications

Hogan Lovells Publications

Congress Enacts Comprehensive Addiction and Recovery Act of 2016

On July 22, 2016, the President signed the Comprehensive Addiction and Recovery Act of 2016 (Pub. L. No. 114-198) (CARA), an expansive law intended to address the prescription opioid abuse...

Hogan Lovells Publications

President to Sign Food and Drug Administration Safety and Innovation Act: Summary of Certain Key Provisions

President Obama is expected to soon sign into law the Food and Drug Administration Safety and Innovation Act (FDASIA). When signed, FDASIA will reauthorize for another five years the...

Published Works

Partners Lynn Mehler and David Fox Co-Author "Controlled Substances Act: FDA and DEA Regulation of Pharmaceuticals"

FDA pharma/biotech partners Lynn Mehler and David Fox have co-authored a primer published by The Food and Drug Law Institute. Titled "Controlled Substances Act: FDA and DEA Regulation of...

Published Works

Controlled Substances: FDA and DEA Regulation of Pharmaceuticals

"Controlled Substances: FDA and DEA Regulation of Pharmaceuticals" is a must-have Primer for stakeholders working with controlled substances. With the user-friendly, practical guidance,...

Hogan Lovells Publications

Preemption Defense Available to Generic Drug Manufacturers

On June 23, 2011, the United States Supreme Court held in Pliva, Inc. v. Mensing that the Food, Drug, and Cosmetic Act (FDCA) and federal drug regulations applicable to generic drug...

Hogan Lovells Publications

U.S. Supreme Court MATRIXX Decision Rejects Statistical Significance as Bright-Line Test of Materiality

In its unanimous opinion in Matrixx Initiatives, Inc. v. Siracusano issued on March 22, the U.S. Supreme Court reaffirmed its long-established standard for determining materiality with...

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