What Are the OTC Drug Label Requirements?

Over-the-counter (OTC) drugs must follow strict FDA labeling requirements to ensure consumer safety. Proper labels include active ingredients, uses, dosage instructions, warnings, and [...]

FDA and FTC Legal Boundaries for Cosmetics

Navigating the legal boundaries for cosmetics in the U.S. requires understanding the distinct roles of the FDA and FTC. The FDA oversees product safety, labeling, and classification, ensuring [...]

What Are FDA Warning Letters and How Do They Impact You?

FDA Warning Letters are formal notifications issued when the FDA finds significant regulatory violations in areas like labeling, marketing, or manufacturing practices. While a warning letter [...]

Advertising Compliance for Medical Devices: FTC and FDA Requirements

The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) finely regulate the promotion compliance of medical devices—both in terms of the claims made and in the manner of [...]

How Developers Can Benefit from the FDA’s Center for Devices and Radiological Health (CDRH) New Innovation Policies

In the last decade, the FDA’s Center for Devices and Radiological Health (CDRH) has implemented many new programs to help developers obtain authorization of medical devices

FDA Grants Accelerated Approval for a New Alzheimer’s Disease Treatment

The FDA recently approved the drug, of Leqembi, a treatment of Alzheimer’s disease, through the accelerated approval process.

FDA Laws and Regulations About The Metaverse

Many metaverse augmented reality, virtual reality, artificial intelligence, and other med-tech applications will need to meet FDA medical device requirements.

Legal Compliance Issues for Integrative Cardiology

Integrative cardiology practitioners, doctors and non-physicians, need to review their working relationship for violations of state licensing laws, HIPAA, self-referral laws, and other legal [...]

HIPAA and Access. Legal Summary and Recent Investigations

The HHS Office of Civil Rights has guidance on how and when covered entities should respond to a right of access request for the personal health information of a patient.

Relaxing Vaccine Dosage and Food Label Requirements

The Food and Drug Administration issues a press release that said, even though the pandemic is severe, patients should receive the mRNA vaccines in two properly timed doses.

Johnson and Johnson’s COVID-19 Vaccine Should Be Reviewed by FDA Soon

Johnson & Johnson’s adenovirus-based vaccine for preventing the transmission of COVID-19 is expected to be reviewed by the Food and Drug Administration in February 2021.

FDA Approves Authorized Use of a COVID-19 Test Product

FDA granted emergency use authorization to Lucira Health Inc. for a COVID-19 self-testing kit. The EUA has numerous conditions that the manufacturer must meet.

FDA Issues Emergency Use Authorization for Pfizer COVID-19 Vaccine

FDA granted an Emergency Use Authorization to a COVID-19 vaccine developed by Pfizer, Inc. Doses of the vaccine have already been administered to health workers

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 [...]

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

Red Flags that Leads to FDA Warning Letters

The FDA issues warning letters for numerous products including dietary supplements. FDA violations include findings that the supplement is a new drug, product adulteration, misbranding, and [...]

Medical Tourism Model can raise FDA and FTC Legal Issues

Jane’s Herbal Healthcare Startup is an ambitious collaboration with overseas physicians who use herbal medicine to treat certain diseases, based on some theory from another, indigenous system of [...]

Why Health Companies Need to Know How the FDA and FTC Enforce Regenerative Medicine Industry Violations

Avoid or mitigate potential FDA and FTC enforcement actions against stem cell and regenerative healthcare companies, including for false claims, by learning these legal keys

Why the FDA Won’t Approve Your Regenerative Medicine Practice

Regenerative medicine includes many treatments and products such as stem cell therapy, PRP, and gene therapy. An experienced stem cell and regenerative medicine lawyer can explain the FDA requirements.

New Farm Bill Opens Up Opportunities for the CBD Oil Market- If Companies Comply with the Legal and Regulatory Requirements

The Farm Bill of 2018 legalized CBD products that are hemp based for certain pharmaceutical uses. Food and dietary supplement possibilities may follow. Many different federal and state laws and [...]

Need-to-Know Laws and Regulations for Regenerative Medicine

Regenerative medicine includes products and treatments that can be regulated by the Food and Drug Administration. The laws are changing as this industry evolves.

FTC Revised Online Endorsement Guidelines

Answers to commonly asked questions about the new Federal Trade Commission (FTC) endorsement guidelines.

Signs that shape the landscape of the healthcare industry

Healthcare venture should always look out for unlicensed practice of medicine issues.

Hoping to Take Advantage of the New Medical Possibilities with Stem Cell Therapies? Be Informed.

The FDA has developed new guidelines that expand the safety requirements and manufacturing standards for stem cell treatments.

3 FDA Legal Traps When Marketing your Dietary Supplement Product

Learn how to avoid these FDA legal traps when marketing your dietary supplement product.

7 Legal Keys to Getting Your OTC Drug to Market

Wondering how to get your OTC drug to market? This FDA OTC drug primer tells you how.

10 Legal Tips to Stop FDA from Classifying Your Dietary Supplement as a Drug

Your dietary supplement products could be regulated as a new drug by FDA, unless you pay attention to these regulatory fundamentals.

Physicians & Healthcare Startups: Don’t Mess with Alphabet-Soup Lettered Government Agencies

Physicians and healthcare startups beware of FDA, FTC, and medical board liability: what you don’t know.

5 Mistakes in Dietary Supplement Labeling that Could Land you in FDA or FTC Enforcement Trouble

Many of our dietary supplement companies come to us with various mistaken assumptions with respect to labeling their dietary supplement products. Let’s talk about 5 key dietary supplement [...]

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 [...]

FDA Dietary Supplement Labeling Requirements: Comply or Die

FDA labeling is one of the most important regulatory requirements for dietary supplements in that it provides the consumer the necessary information on the product. Indeed, ensuring that all [...]

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 [...]

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 [...]

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 [...]

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.

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 [...]

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