Tag Archives: FDA

Seven Key Questions in Understanding the Current Regulatory State of HCT/Ps

13-Lab
Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air.  Learn what you need to know quickly with these seven questions and answers. What do I Need to Know?… Continue reading this entry

Three Dozen States Sue Makers of Opioid Addiction Treatment Medications for Antitrust

Hundred-Dollar-bill_RX_300x225
With opioid abuse continuing to dominate national headlines, manufacturers of opioid overdose medications are facing intense scrutiny over pricing practices that threaten (or those perceived as threatening) public availability of these medications.  In March 2015, for instance, Congress investigated “price hikes” by Amphastar Pharmaceuticals, Inc. (“Amphastar”) for naloxone (sold under the brand name Narcan®), a … Continue reading this entry

FDA Outlines Future Medical Device Coordinating Center

7
The federal Food and Drug Administration’s planning board (Planning Board) for a medical device evaluation system (NMDES) recently recommended the creation of a centralized Coordinating Center to develop a national system to evaluate medical devices. Convened in 2014 by the U.S. Food and Drug Administration (FDA) and the Brookings Center for Health Policy, the Planning … Continue reading this entry

Federal Agencies Provide User-Friendly Guidance on Compliance with Data Privacy Laws

CyberSecurity
How federal privacy laws apply to mobile health applications has been an area of significant ambiguity. Recently, the Federal Trade Commission’s (FTC), the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR), the Food and Drug Administration (FDA), and the HHS Office of the National Coordinator for Health Information Technology (ONC) … Continue reading this entry

Amarin Pharma Settles First Amendment Claims Against FDA: Potential Implications

Courtroom
Irish drug company Amarin Pharma, Inc. (Amarin) and the U.S. Food and Drug Administration (FDA) agreed, on March 8, 2016, to settle claims that FDA regulations barring Amarin from making “truthful” and “non-misleading” statements about off-label uses for its omega-3 drug, Vascepa, violated Amarin’s right to engage in constitutionally protected speech. The underlying claims and settlement may have … Continue reading this entry

Is My Telehealth App Subject to HIPAA?

7
Many telehealth and mHealth app developers are concerned about whether or not their app is a medical device under FDA regulations (and rightfully so), they often pay less attention to the Health Insurance Portability and Accountability Act (“HIPAA”) rules. The developer either mistakenly presumes HIPAA applies to their app or neglects to consider health privacy issues … Continue reading this entry