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Healthcare › Patients › Food and Drug Administration (FDA)

Searcy Denney Scarola Barnhart & Shipley

Recalled Medical Devices: How to Check If You Have One

Searcy Denney Scarola Barnhart & Shipley on

Numerous medical devices sold in the United States are subject to active recalls. If you have a medical device that is subject to an active recall, it will be important to make sure you know what this means for your health...more

Napoli Shkolnik

What Is Polypharmacy And Why Should You Care?

Napoli Shkolnik on

Polypharmacy is Medspeak for taking more than one prescription medication at a time. About one in five Americans over age 49 is a polypharmicist, of sorts....more

Foley Hoag LLP

Fostering More Access to Medical Devices: FDA’s Efforts to Advance Health Equity

Foley Hoag LLP on

On August 5, 2024, FDA’s Center for Devices and Radiological Health (CDRH) published a discussion paper entitled, “Discussion Paper: Health Equity For Medical Devices” (Discussion Paper), to aid in its efforts to advance...more

McDermott Will & Schulte

OIG Issues General Compliance Program Guidance Updates

McDermott Will & Schulte on

On November 6, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published the General Compliance Program Guidance (GCPG) as a revised reference guide for the healthcare compliance...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Legislative Efforts to Remove Impediments to Biosimilar Approvals and Marketing

Rothwell, Figg, Ernst & Manbeck, P.C. on

Biosimilars are becoming increasingly important in healthcare as they offer a lower-cost alternative to biologic drugs, which can be expensive for patients, governments, and insurers. These biologic medicines, which are...more

Searcy Denney Scarola Barnhart & Shipley

FDA: Blood Volume Expanders Present Severe Risks for Patients

Searcy Denney Scarola Barnhart & Shipley on

On July 7, 2021, the U.S. Food and Drug Administration (FDA) issued new warnings regarding hydroxyethyl starch (HES) blood volume expanders. Specifically, the FDA is now requiring manufacturers to update the safety labels for...more

Faegre Drinker Biddle & Reath LLP

FDA Solicits Feedback to Create Consistent Process for Labeling Devices

Faegre Drinker Biddle & Reath LLP on

The Food and Drug Administration Center for Devices and Radiological Health is soliciting feedback on how materials information about medical devices should be communicated to patients and healthcare providers. On May 20,...more

Searcy Denney Scarola Barnhart & Shipley

FDA Warns of Risk of Failure in Stryker STAR Ankle Replacement Devices

Searcy Denney Scarola Barnhart & Shipley on

The U.S. Food and Drug Administration (FDA) is warning patients and healthcare providers of a “higher than expected risk” of failure in Stryker Scandinavian Total Ankle Replacement (STAR) devices. According to the FDA, the...more

Sheppard Mullin Richter & Hampton LLP

Patient Empowerment Through Technology is Focus of ENGAGE Conference

Sheppard Mullin Richter & Hampton LLP on

This follows the blog article posted November 28, “Connection and Innovation Take Center Stage at the Patient ENGAGE Conference” and is the second feature regarding the MedCity ENGAGE conference Nov. 6-7 in San Diego. Here,...more

Patrick Malone & Associates P.C. | DC Injury...

FDA data underscores why patients need to ask tough questions about care

Patrick Malone & Associates P.C. | DC Injury... on

The epidemic of overtreatment is hardly new, and it often stems from physicians’ tendency to order excessive tests. But now Uncle Sam is getting ready to step in even more, prompted in part by disturbing data that detailed...more

Foley & Lardner LLP

AmerisourceBergen Guest Post: Solutions to Overcome Reimbursement Challenges in Personalized Medicine

Foley & Lardner LLP on

The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is...more

Robins Kaplan LLP

PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA

Robins Kaplan LLP on

The rise of social media has introduced new opportunities and new legal challenges for companies in the health care industry. Attorneys Seth Northrop and Sharon Roberg-Perez discuss the legal issues faced by care providers,...more

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