Sheryl Rosen on Food and Drug Administration (FDA)

Dose of Caution Needed When Making Coronavirus Drug Claims

Just like the dose makes the poison, the claim makes the drug. With a pandemic well underway, some marketers are offering products that they claim will treat or prevent COVID-19, the disease caused by the novel...more

4/19/2020 / Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Misleading Statements , Pharmaceutical Industry , Prescription Drugs , Supply Chain

FDA Ponders Health and Safety of Lab-Grown Meat

The hamburger of the future might be less Old MacDonald and more sci-fi – and it might be here sooner than you think. Several startups are working to scale up animal cell culture technology to grow meat tissue for human...more

7/2/2018 / Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , Regulatory Oversight , Regulatory Requirements

The Changing Meaning of Healthy: FDA Seeks Public Input About Healthy Foods

In the 1990s, food had to be low in fat in order to be considered healthy. Those were the days of Snack-Wells cookies and fat-free salad dressings. How times have changed. Now health professionals consider many higher-fat...more

9/30/2016 / Comment Period , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Food Marketing , Healthcare

Protecting the Blood Supply During a Future Ebola Outbreak

It has been more than a year and a half since the Ebola outbreak began racing across western Africa. According to the U.S. Centers for Disease Control & Prevention (CDC), more than 28,000 people have been infected. Although...more

12/17/2015 / Centers for Disease Control and Prevention (CDC) , Ebola , Food and Drug Administration (FDA) , Healthcare , Infectious Diseases

Food Recalls Increase in First Quarter of 2015

Food producers are reporting a sharp rise in food recalls so far this year. During the first quarter of 2015, the U.S. Food and Drug Administration (FDA) published notices of 118 food recalls (excluding pet foods), and the...more

4/21/2015 / Food and Drug Administration (FDA) , Food Manufacturers , Food Recalls , Food Safety , USDA

Guidance Helps Medical Device Companies Determine Substantial Equivalence

When is a medical device substantially equivalent to another device? Like so much else, it depends. On July 15, 2014, the U.S. Food and Drug Administration (FDA) issued a draft guidance that aims to clarify that question....more

8/5/2014 / Food and Drug Administration (FDA) , Healthcare , Medical Devices

FDA Offers Guidance for Choosing Prescription Drug Names

If you've seen your share of prescription drug commercials, you've likely marveled at the odd drug names: Moexipril. Oxcarbazepine. Zafirlukast. You might think pharmaceutical companies just prefer complex, new combinations...more

7/1/2014 / Food and Drug Administration (FDA) , Marketing , Pharmaceutical Industry , Prescription Drugs

FDA Launches Medical Device ID Requirement

On September 24, 2013, the Food and Drug Administration (FDA) finalized a new rule requiring medical devices to bear special ID numbers. The numbers, called Unique Device Identifiers or UDIs, will identify the manufacturer,...more

10/1/2013 / Food and Drug Administration (FDA) , Labeling , Manufacturers , Medical Devices , Unique Device Identifiers

Sheryl Rosen

Akerman LLP

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