Month: September 2018

New Draft Guidance Regarding Data Sharing on ClinicalTrials.gov and Civil Money Penalties

On September 21st, the U.S. Food and Drug Administration (“FDA”) published a draft guidance document titled “Civil Money Penalties Related to the ClinicalTrials.gov Data Bank” (“Draft Guidance”) regarding the imposition of civil money penalties (“CMPs”) for failure to submit required clinical trial information to ClinicalTrials.gov or improperly certifying compliance with […]

OIG Advisory Opinion Permits Refunding Device Purchase Price Under Limited Conditions

On September 17, 2018, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 18-10 regarding a proposed arrangement in which a surgical device and wound care product manufacturer (“Manufacturer”) will offer its hospital customers (“Customer”) who purchase the following three products for use in a joint replacement surgery: (i) […]

HHS Announces Innovation and Investment Summit

Yesterday, Department of Health and Human Services Deputy Secretary Eric Hargan announced the launch of the Deputy Secretary’s Innovation and Investment Summit (DSIIS).  DSIIS follows a June 2018 request for information to “develop a workgroup to facilitate constructive, high-level dialogue between HHS leadership and those focused on innovating and investing […]