In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA.
Hear from Joanne Hawana and Ben Zegarelli, FDA specialists...more
The Food and Drug Administration (FDA) continues to churn out policy statements, guidance documents, and emergency use authorizations (EUAs) to address the COVID-19 public health emergency. At the outset of the pandemic in...more
This post is the first in a series of three in which we recap the Food and Drug Administration’s somewhat difficult year, having spent the majority of it without a permanent Commissioner and facing a slew of political and...more
12/5/2019
/ 21st Century Cures Act ,
Clinical Laboratories ,
Digital Health ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Life Sciences ,
Medical Devices ,
Regulatory Agenda ,
Regulatory Oversight ,
Statutory Authority
On August 8, 2019, FDA issued a notice on its medical device recall database stating that a company called Opternative, Inc. had initiated a recall for the Visibly Online Refractive Vision Test, a software application offered...more
Regulation of cannabidiol (CBD) was a hot topic on Day 1 of ACI’s Cosmetics & Personal Care Products conference on March 28, 2019. Attendees asked many questions about legitimate uses of and claims for CBD, but definite...more
4/1/2019
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Cosmetics ,
DEA ,
Dietary Supplements ,
Food and Drug Administration (FDA) ,
Health and Safety ,
Hemp ,
Labeling ,
Legislative Agendas ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Regulatory Oversight
The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the “SUPPORT for Patients and Communities Act”) – which is intended to combat the spread and pernicious...more
11/13/2018
/ Anti-Kickback Statute ,
Clinical Laboratories ,
Health Care Providers ,
OIG ,
Opioid ,
Pain Management ,
Patient Referrals ,
Regulatory Oversight ,
Regulatory Requirements ,
Remuneration ,
Safe Harbors ,
Secretary of HHS
On February 22, the Wall Street Journal published an article about the tissue graft manufacturer MiMedx Goup, Inc. and its failure to report payments to physicians under CMS’s Open Payments Program established by the Centers...more
3/8/2018
/ Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Disclosure Requirements ,
Enforcement Actions ,
Failure to Report ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Open Payments ,
Physicians ,
PPSA ,
Regulatory Oversight ,
Reporting Requirements ,
Social Security Act
This is our third installment in our series about the legal issues involved in launching a health app, which the U.S. Food and Drug Administration (“FDA”) refers to as “mobile apps.” The goal of this post is to provide you...more
10/3/2017
/ 21st Century Cures Act ,
Electronic Medical Records ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Devices ,
Medical Records ,
Mobile Apps ,
Mobile Health Apps ,
Pharmaceutical Industry ,
Regulatory Oversight