Tag Archives: FDA

Public Policy August Recess Health Care Newsletter  

Public Affairs
Foley’s  Bipartisan Public Policy Team is pleased to share our Public Policy August Recess Health Care Newsletter  in which we compiled the top health care policy news and legislation from this month. The House was not in session and the Senate came back mid-month to focus on passing appropriation bills and presidential nominations. This Week in … Continue reading this entry

Health Care Policy Newsletter

Foley & Lardner LLP’s Bipartisan Public Policy Team is pleased to share this week’s “Public Policy Health Care Newsletter” in which we compile the latest health care policy news and legislation. Please note that the next newsletter will be published on August 27th.… Continue reading this entry

Health Care Policy Newsletter

Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health care policy news and legislation. *Please note that we publish this newsletter only when Congress is in session. This Week in Health Care Policy (June 25-29, 2018)… Continue reading this entry

Health Care Policy Newsletter

Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health care policy news and legislation. *Please note that we publish this newsletter only when Congress is in session.… Continue reading this entry

Health Care Policy Newsletter

Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health care policy news and legislation. *Please note that we publish this newsletter only when Congress is in session.… Continue reading this entry

Health Care Policy Newsletter

Policy
Foley’s Bipartisan Public Policy Team  is pleased to share our “Public Policy Health Care Newsletter” in which we compile the latest health care policy news and legislation. *Please note that we publish this newsletter only when Congress is in session.… Continue reading this entry

Health Care Policy Newsletter

Public Affairs
Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team  is pleased to share our “Public Policy Weekly  Health Care Newsletter” in which we compile the latest health care policy news and legislation. *Please note that we publish this newsletter only when Congress is in session.… Continue reading this entry

This Week in Health Care Policy

Public Affairs
Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to introduce “This Week in Health Care Policy,” a new weekly publication providing a compilation of  the latest health care policy news and legislation. This newsletter will be provided on weeks that Congress is in session. The first edition appears below.… Continue reading this entry

New FDA Commissioner Hits the Ground Running

FDA
Fresh off his noticeably smooth confirmation, the new Commissioner of Food and Drugs, Dr. Scott Gottlieb, appeared before Congress last Thursday and unveiled his strategic initiatives and priorities for the Trump Food and Drug Administration (“FDA”).  These run the gamut from improving regulatory science and policies to streamlining clinical trials to spurring innovation on behalf … Continue reading this entry

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

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

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

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

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

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?

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