Healthcare & FDA Law Blog

What Happens If You Make a Food with Hemp, Cannabis, or THC – Part One

Healthcare makers, distributors, and sellers must comply with FDA rules and warning letters for their cannabis, hemp, and THC products including foods, OTC drugs, cosmetics, and dietary supplements

FDA Issues Warning Letter to Company that Sells CBD Products Online and Through Social Media

FDA sends warning letter to a company because its website and social media accounts made claims about CBD products that suggest they are drugs or dietary supplements and were misbranded.

New HHS 21st Century Cures Act IT Rule – Part 2

These are two more of the non-fulfillment exceptions to the ONC rule. Another three fulfillment exceptions follow. The exceptions try to balance the ability of the developers and practitioners to provide technical and medical solutions with the patient’s desire for privacy and security of his/her medical records.

New HHS 21st Century Cures Act IT Rule – Part 1

The Office of the National Coordinator for Health Information Technology (ONC), which is part of the Department of Health and Human Services, approved a final rule which implements certain provisions of the 21st Century Cares Act.

Why Medical Device Companies Need to Fear FDA Warning Letters

The FDA examines whether medical devices comply with the regulations of the Food, Drug, and Cosmetic Act. Two of the most common violations medical device companies are charged are adulteration of the products and misbranding.

New Proposed Rules from the CMS and the OIG-HHS on Stark Law and from the Anti-Kickback Statute

The CMS and HHA are proposing new rules, such as the Patients over Paperwork Initiative, where the focus of Stark and AKS will be on value-based arrangements

How to Resolve Healthcare Legal Roadblocks & Make the Most of Your Healthcare Lawyer

What is it that you want to get out of talking to a healthcare lawyer, an FDA lawyer or really any lawyer?

Judge Confirms FDA Regulation of Stem Cell Industry

A federal judge confirmed that the FDA has the right to regulate for-profit stem-cell therapy treatments. Autologous treatments may require FDA approval as drugs.

FDA Warning Letters Can Cause Cosmetic Companies to Lose Revenue and Face Substantial Fines

FDA might classify your cosmetics product as a new drug if you make disease claims for your cosmetics product. FDA also requires that you substantiate your claims and have safe ingredients

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