You’ve seen the news about insufficient supply and availability of ventilators to treat patients with Coronavirus Disease 2019 (COVID-19). You’ve also likely seen news of ideas to mitigate this shortage. On March 24, 2020 FDA issued an Emergency Use Authorizations (EUA) for ventilators, anesthesia gas …
As part of a larger COVID-19 outbreak response effort, many state pharmacy regulators have issued waivers or temporary suspensions of certain pharmacy laws. The California State Board of Pharmacy, State of Ohio Board of Pharmacy, Pennsylvania Department of State, and Texas State Board of Pharmacy …
FDA is exercising significant emergency authorities during the COVID‑19 pandemic. Not all of industry is affected, but those who are manufacturing or distributing (or using) devices being used to fight the pandemic can benefit by understanding FDA’s emergency‑related policies and practices. These are evolving every …
In 2009, Levon Helm, formerly of The Band, wrote and recorded “Growin’ Trade,” a song about a weary, disillusioned American farmer reluctantly staves off bankruptcy by growing illegal cannabis. Helm nor anyone else could have known that in the ensuing years, a majority of states …
For the past two years, FDA has been working to improve the 510(k) Third Party Review Program. This program is meant to delegate the review of certain 510(k) submissions, freeing FDA’s limited resources to focus on the review of more complex devices and those that …
The COVID-19 pandemic has had a significant impact on day-to-day life for all of us in an attempt to “flatten the curve” to slow transmission of the coronavirus (SARS-CoV-2). However, for those of us involved in the development of medical products, quarantines, site closures, travel …
With the growth of biosimilar applications, courts have been faced with a litany of questions arising from the interplay between reference product intellectual property and the biosimilar application process. Though the BPCIA was designed to “learn” from FDA’s experience with the Hatch-Waxman Act, the procedural …
A month ago, we blogged on FDA’s emerging strategy of granting Emergency Use Authorizations (EUAs) for devices, drugs, and biologics that can be used to combat the spread of COVID‑19. Since then, FDA has begun granting EUAs, with more in the pipeline. In addition, the …
Since as early as 2005, industry has asked FDA for its input on the listing of device patents in the Orange Book (see our previous post here). FDA has, for the most part, refused to address this question. As such, industry has decided to just …
Last week, FDA submitted to Congress the report on CBD (“CBD Report”) that the agency was directed to prepare by the Further Consolidated Appropriations Act, 2020. Concurrently, the Commissioner issued a statement that summarizes the agency’s progress to date, and a consumer update that emphasizes …
Last Thursday, March 5, 2020, the FTC filed a formal complaint alleging deceptive marketing practices against tea and skincare company, Teami, LLC, and its co-founders, as well as a stipulated order for permanent injunction and monetary judgment. In conjunction with the filings, the FTC also …
The recent opinion in FTC v. Quincy Bioscience Holding Co., 2020 U.S. Dist. LEXIS 36424*(S.D.N.Y. Mar. 2, 2020) (background here) is a primer on affirmative defenses in an FTC Act case alleging deceptive advertising of a dietary supplement. The FTC and State of New York …
Judge Naomi Buchwald of the District Court for the Southern District of New York recently found that the Department of Health & Human Services (“HHS”) misinterpreted a federal law requiring it to collect and post data for certain clinical trials, resulting in a 10-year gap …
In a recent decision out of the Seventh Circuit, Antrim Pharms. Llc. v. Bio-Pharm, Inc., 2020 U.S. App. LEXIS 4772* (7th Cir. 2020), the court decided a battle of the experts: Bio-Pharm prevailed after Antrim unsuccessfully argued the court should preclude testimony by Bio-Pharm’s expert, HP&M’s …
On February 27, the U.S. Department of Agriculture (USDA) announced the delay of enforcement of certain requirements under the interim final rule (IFR) for the U.S. Domestic Hemp Production Program. As we previously reported, on Nov. 7, 2019, USDA published its much-anticipated rule establishing the requirements …
