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Mobile health apps must comply with FDA regulations, HIPAA privacy laws, and FTC advertising guidelines to avoid enforcement actions. Learn how to determine if your app is a medical device, [...]

The FDA’s Center for Drug Evaluation and Research conducted a study examining the relationship between disease communications and prescription drug advertising. The results are discussed

The Center for Drug Evaluation (CDER), in 2017, developed an initiative to modernize CDER’s New Drugs Regulatory Program (NDRP). The initiative focuses on scientific leadership, benefit-risk [...]

The FDA approved a new Eli Lilly drug, Kisunla, that may help reduce the cognitive decline of Alzheimer’s patients by attacking the patient’s amyloid. The drug is the third FDA-approved drug of [...]

Pharmaceutical companies and advertisers should consult FDA’s CNN rule when designing television and radio ads for direct-to-consumer drug advertisements

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

Individuals and companies that make and market aromatherapy products need to understand when the products may be considered drugs by the FDA and when the FDA will consider that the products are [...]

Artificial manufacturers need to understand the FDA approval process for medical devices and drugs. Physicians need to understand AI uses and patient privacy issues.

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

The FDA has approved Transcranial Magnetic Stimulation (TMS) treatments for depression and obsessive-compulsive disorders. Other treatments may be FDA-approved based on the substantial [...]

Developers and manufacturers of medical devices need to understand 510 (k) approval of medical devices and other FDA compliance issues.

Developers and manufacturers of medical devices need to understand how FDA classifies the devices and the criteria for approval

Developers and manufacturers of stem cell therapies need to understand how to conduct clinical trials in order to process FDA investigational new drug (IND) applications.

The FDA’s Center for Biologics Evaluation and Research (CBER) regulates stem cell products. Stem cells normally require an investigational new drug application.

3D printing is being used for prosthetics, orthodontics, surgical preparation, and other applications. These devices may be subject to FDA regulation, Stark and AKS compliance, and FTC oversight.

We review in more detail the role of the FDA in the regulation of medical imaging analysis software – whether it’s used as part of a mobile application, laboratory analysis, or for other medical [...]

New medical imaging software benefits many different types of health practices. Key compliance issues include HIPAA and FDA oversight.

What mobile mental health app manufacturers and the physicians who recommend and use these apps need to understand about FDA regulation of medical devices.

Medical practices and developers need to understand the federal regulations that govern the development and use of digital health products including medical device data systems, mobile medial [...]

The FDA does have authority to regulate medical devices – including digital health technologies that qualify as medical devices. Digital health includes SaMD, AI, ML, medical mobile apps, and [...]

Immunotherapy drugs are showing promise for treating cancer. Manufacturers of these therapies and doctors must understand the FDA, HIPAA, and other compliance requirements.

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

Many companies are making and selling products with herbs and other adaptogens that claim to relieve stress and need to understand the FDA regulations that regulate drugs and dietary supplements.

Homeopathic medicine is an alternative medical practice that appeals to millions of people. Anyone involved with the practice of homeopathy needs to understand FTC compliance issues.

FDA is sending warning letters to companies that claim the company can diagnose COVID-19. FDA has granted an Emergency Use Authorization) for at least one at-home testing kit.

An Advisory Panel for the Food and Drug Administration is reviewing a request by Moderna for its COVID-19 vaccine. Moderna’s vaccine is expected to be distributed in the coming months.

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 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

The Federal Trade Commission (FTC) and Federal Drug Administration (FDA) are continuing to send warning letters to companies that promise treatments and cures for COVID-19

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

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

We’ve counseled hundreds and hundreds of healthcare companies, ventures and practices over the last 30 years. I’d like to talk to you about the difference between what makes a successful [...]

California Department of Public Health (CDPH) does not authorize CBD-infused foods. The Farm Bill does make hemp an agricultural product. The FDA may approve CBD-based drugs through scientific [...]

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

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

Michael H Cohen has been interviewed by the Medical Ethics Advisor, a well established publication that focuses on current healthcare issues.