9/12/2024 4:59:01 PM FDA Serves Up a Stricter Enforcement Standard for Celebrities Endorsing Rx Drugs By Jim Czaban Being a celebrity has its challenges. Adding a new one to the list, the U.S. Food and Drug Administration (FDA) has recently issued an...
6/28/2024 6:53:41 PM R.I.P. Chevron Deference (1984-2024); Is FDA Newly-Vulnerable to Legal Challenges? By Jim Czaban The Supreme Court on June 28, 2024 put the final nail in the coffin of so-called "Chevron deference," a key judicial doctrine that has...
3/13/2024 9:08:10 PM Are FDA Astronauts Coming Soon? Implications of the Revolution in Space-Based Drug Manufacturing By Jim Czaban Recent news reports have described the successful progress of at least one company, Varda Space Industries, in developing a space-based...
1/31/2024 8:49:57 PM Lessons Learned: FDA Digs Up, and Discards, Time-Capsule Citizen Petition Re: Online Drug and Device Promotion By Jim Czaban The FDA Citizen Petition ("CP") process is a widely used, but often seemingly fruitless tool by which interested persons and entities can...
11/21/2023 5:41:07 PM The AI Pin: Fashion-Forward or Tech's Next Big Thing? By Melanie J. Howard Kristen R. Klesh Humane has launched public orders for its AI Pin. According to founders Imran Chaudhri and Bethany Bongiorno (former Apple employees),...
11/15/2023 2:37:26 PM FDA's First Interchangeable Biosimilar Exclusivity Decision -- Prelude to a New Wave of FDA Litigation? By Jim Czaban FDA has released an 18-page internal decision memo which for the first time lays out the agency's interpretation of how regulatory...
11/14/2023 5:47:09 PM Demand for Weight Loss Drugs: Pounds Drop, but Counterfeit-Related Hospitalizations Rise By Kristen R. Klesh Melanie J. Howard Admittedly, the topic of weight loss isn't the ideal “Turkey-Day” conversation starter. Nevertheless, when the discussion relates to a...
11/8/2023 10:39:08 PM FTC's New Orange Book Listing Complaints Target Drug Delivery Device Patent Issue That FDA Has Ignored For Years By Jim Czaban The Federal Trade Commission (FTC) is at it again, jumping into the Food and Drug Administration's sandbox with a splashy press release...
11/6/2023 7:04:08 PM Is "Good for You!" a Health-Related Marketing Claim? Context is King, According to Minute Maid Case By Kristen R. Klesh The phrase “Good for You!” can take on a variety of meanings, ranging from a statement of congratulations to a sarcastic dig, depending...
10/26/2023 4:48:09 PM FDA's New Off-Label Reprint Guidance – "Standing Alone" Enforcement Doctrine Rears Its Head Again By Jim Czaban In October 2023, the Food and Drug Administration (FDA) published its latest iteration of a draft Guidance on dissemination of...