Publications

Hogan Lovells Publications

FDA pushes "consumer-friendly" presentation of quantitative data in DTC promotions

On Tuesday, the Food and Drug Administration (FDA or the agency) published a draft guidance document, "Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer...

Hogan Lovells Publications

New regulations expand CFIUS' jurisdiction and mandate filings

The Department of the Treasury has released two new interim rules that (i) update existing regulations regarding the Committee on Foreign Investment in the United States (CFIUS) pursuant to ...

Hogan Lovells Publications

The Italian Competition Authority is taking a close look at the food supplement market

Co-authored and co-written by Carlotta Busani, Trainee Solicitor.

Hogan Lovells Publications

New draft guidance proposes a shift in how the FDA will evaluate certain device modifications

On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k) Program," which, when finalized, will...

Published Works

Medical device crowdfunding and preapproval promotion: Where does FDA draw the line?

The medical device industry has long sought more comprehensive guidance from the Food and Drug Administration (FDA or the agency) regarding the line between appropriate and inappropriate...

Hogan Lovells Publications

New anti-kickback prohibition in opioid bill creates tangled web of compliance obligations

On October 3, the U.S. Congress passed H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the SUPPORT...

Hogan Lovells Publications

FDA schedules public hearing on solutions to drug shortages

The U.S. Food and Drug Administration (FDA) has announced it will hold a public meeting on November 27 in Washington, D.C. to give stakeholders – including health care providers,...

Published Works

The skilled machines disrupting drug design

Capable of identifying novel compounds for therapeutic use, AI is saving time and costs in a process that can take around 10 to 15 years and billions of pounds to complete.

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