Publications

Hogan Lovells Publications

FIG Bulletin, 12 October 2018

We are delighted to send you our latest e-newsletter, setting out developments from 8th to 12th October 2018.

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

New draft guidance proposes a shift in how the FDA will evaluate certain device modifications

On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k) Program," which, when finalized, will...

Hogan Lovells Publications

Department of Transportation announces updates to policies and rule-makings regarding autonomous vehicles

The U.S. Department of Transportation (DOT) has released an update to the agency's policy document on autonomous vehicles.

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,...

Hogan Lovells Publications

OIG gives the green light to another innovative warranty

Last week, the Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion No. 18-10, advising that the OIG would not pursue an enforcement action...

Hogan Lovells Publications

Crackdown coming? Draft guidance suggests FDA is looking more closely at clinical trial disclosures

On Friday, September 21, the Food and Drug Administration (FDA) published a draft guidance titled "Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank."

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