FDA has repeatedly declared that cannabidiol (“CBD”) cannot be lawfully used in food or dietary supplements because FDA approved CBD as an active ingredient in an epilepsy drug before the first marketing of CBD as a dietary supplement or food. This has not stopped the …
Just as many object to holiday music in November, the Office of Prescription Drug Promotion (“OPDP”) objected in an untitled letter issued earlier this month to claims made for an investigational drug. The statements (since removed) appeared on a company website about an investigational drug …
On November 13, 2019, the National Academies of Sciences, Engineering, and Medicine (NASEM) Forum on Regenerative Medicine hosted a workshop on Exploring Novel Clinical Trial Designs for Gene-Based Therapies. The Forum was tasked with exploring the design complexities and ethical issues associated with gene- and …
In October, FDA issued a draft guidance titled “Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act,” which will replace a similar April 2011 draft guidance once finalized. This new draft guidance reflects a significant expansion of FDA’s …
The Government Accountability Office released a new Report last week focusing on the oft-analyzed tactics used by some innovator or brand-name pharmaceutical manufacturers to keep generic versions of products off the market. Like some facets of then-Commissioner Gottlieb’s Drug Competition Action Plan, the GAO Report …
On October 23, 2019, the U.S. Cattlemen Association (USCA) petitioned USDA regarding Made in USA and Product of USA and similar claims on beef. USCA explains that it is concerned that voluntary “Made in USA” labeling for beef products, without a clear definition of what constitutes …
On November 5, 2019, the U.S. District Court for the Northern District of California ruled in favor of Theranos founder Elizabeth Holmes and former Theranos president Sunny Balwani, in a battle over access to government documents. While this represents a small victory for these defendants, …
On November 5, 2019, the U.S. District Court for the Northern District of California added another entry in the long running saga United States ex rel. Campie v. Gilead Sciences, Inc. when it granted the DOJ’s motion to dismiss. We have extensively covered this case …
FDA is issuing final guidance on how device firms may request review of a decision to withhold issuance of a Certificate to Foreign Government (CFG). What is a CFG? In many cases, foreign governments will seek official assurance that products exported to their countries are …
Hyman, Phelps & McNamara, P.C. (“HP&M”) has once again been ranked as a “Tier 1” law firm in the area of “FDA Law” (both nationally and in Washington, D.C.) by the folks over at U.S. News & World Report, who teamed up with Best Lawyers …
On November 7, 2019, gene therapy company Regenxbio Inc., filed suit in U.S. District Court in Washington, D.C. against FDA asking the court to set aside a partial clinical hold on one clinical trial and a full clinical trial for another. The complaint also seeks …
USDA published its much-anticipated interim final rule establishing a domestic hemp production program, as directed by the Agriculture Improvement Act of 2018 (a/k/a the Farm Bill). The rule sets out the requirements for hemp production plans developed by States and Indian Tribes that choose to …
Hyman, Phelps & McNamara, P.C. is pleased to publish the third installment of the FDA Law Alert, a quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog. Please subscribe to the FDA Law Blog to receive contemporaneous posts on government regulatory and …
Final rule regarding vending machine calorie labeling Almost 5 years ago, as part of nutrition labeling requirements under the ACA, FDA issued a final rule which requires operators who own or operate 20 or more vending machines to disclose calorie information for food sold from vending …
