Publications

Hogan Lovells Publications

FDA guidances promote greater communication to payors about medical product value

On June 12, FDA finalized two guidance documents regarding the types of information that drug and device manufacturers may communicate to payors and that the agency regards as...

Hogan Lovells Publications

New Jersey issues rules to chill drug manufacturer payments to prescribers

The New Jersey Attorney General plans to finalize new limits on payments and other benefits that New Jersey licensed prescribers may accept from pharmaceutical manufacturers, although the...

Hogan Lovells Publications

In The Midnight Hour: FDA Issues 2 Draft Guidances and a First Amendment Memorandum on the Cusp of a New Administration

Over the past few days, FDA issued three documents related to the scope of permissible communications by drug and device companies to various parties. We believe FDA aimed to accomplish two ...

Hogan Lovells Publications

Short-fuse compliance deadline for expanded access provision in 21st Century Cures Act

Under Section 3032 of the 21st Century Cures Act, manufacturers and distributors of investigational drugs for serious diseases or conditions have 60 calendar days after the date of...

Hogan Lovells Publications

Much to metabolize: The 21st Century Cures Act introduces numerous changes to FDA’s drug regulatory framework to spur development of new treatments

The 21st Century Cures Act (Cures Act) has become law with measures designed to deliver new cures and treatments to patients.  Among these measures are a broad range of changes to the...

Hogan Lovells Publications

FDA got an earful: FDA’s Part 15 public hearing on manufacturer communications regarding unapproved uses of approved or cleared medical products

Last week, FDA held a much-anticipated Part 15 public hearing seeking commentary on its regulation of speech about unapproved uses of approved products. As the agency noted in its Federal...

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

The FDA feels the pain in a court decision about promoting prescription drugs

You’d think that once a drug maker had enjoyed successful clinical trials and received FDA authorization to market its drug, the FDA would move on to other matters. You’d be...

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