0

5 Ways Cosmetic Product Companies Can Comply with FDA Labeling Requirements & Help Avoid FDA Enforcement

Cosmetic products do not require Food and Drug Administration (FDA) approval unless they have color additives or unless the qualify as a drug, medical device, or dietary supplements. There are [...]

0

FDA Signals Tough New Regulatory Stance on Homeopathic Drugs

FDA is changing the playing field by withdrawing its earlier Compliance Policy Guide (CPG) 400.400, Conditions Under Which Homeopathic Drugs May be Marketed, and issuing its new draft Guidance on [...]

0

TELEMEDICINE LEGAL SERIES—PART 5: HIPAA

PRIVACY, CONFIDENTIALITY, AND SECURITY ISSUES ARISE WHEN PRACTICING TELEHEALTH OR TELEMEDICINE JUST AS THEY DO IN A BRICK-AND-MORTAR PRACTICE. IT’S ESPECIALLY IMPORTANT TO UNDERSTAND THESE [...]

0

7-PART TELEMEDICINE LEGAL SERIES—PART 4: STANDARD OF CARE ISSUES

HOW DO HEALTHCARE PRACTITIONERS HANDLE STANDARD OF CARE ISSUES WHEN DIAGNOSING AND TREATING FROM A DISTANCE?

0

TELEMEDICINE LEGAL SERIES—PART 3: E-PRESCRIBING

THE LAW HANDLES TELEMEDICINE PRESCRIPTION DIFFERENTLY THAN DIAGNOSING AND TREATING REMOTELY. HOW CAN YOU BEST COMPLY? PRESCRIBING IS DIFFERENT THAN OTHER TREATMENT

0

TELEMEDICINE LEGAL SERIES—PART 2: LICENSING ISSUES

BECAUSE TELEHEALTH AND TELEMEDICINE OFTEN INVOLVE PRACTICE ACROSS STATE LINES, HEALTHCARE PRACTITIONERS MUST UNDERSTAND THE STATE LAWS WHICH ALLOW PRACTICE IN SITUATIONS WHERE THE HEALTHCARE [...]

0

TELEMEDICINE LEGAL SERIES—PART 1: PRACTICE ISSUES

Healthcare providers who move beyond a brick-and-mortar physical practice often find themselves in a legal gray zone, wondering whether they are compliant, or even what rules might apply. This [...]

0

Off-Label Promotion Has Legal Limits

While recent legal developments have loosened legal strictures around truthful, non-misleading, off-label promotion of drugs, there are legal limits to an off-label promotion strategy. Here [...]

0

Does FDA Deem My Product to be a Medical Device?

Does FDA deem your product to be a medical device, or is it just a consumer product that would not be regulated by FDA? Here are basic steps you can take to work through the puzzle.

0

Federal Trade Commission Slams Homeopathic Drugs

The Federal Trade Commission (FTC) has slammed homeopathic drugs with a guidance document on substantiation. This is perhaps the biggest regulatory backlash against homeopathic medicine since [...]