FDA issued another COVID-related guidance for immediate implementation last week. Citing a substantial increase in the number of requests for individual patient expanded access requests for COVID-19 investigational drugs (which we will use here to include biological products), on June 2, 2020, FDA released a …
The U.S. Department of Agriculture (“USDA”) continues to consider and approve state and tribal hemp production plans, announcing the approval of plans for the U.S. Virgin Islands, Cheyenne River Sioux Tribe, Chippewa Cree Tribe, Lac Courte Oreilles Band of Superior Chippewa Indians, and Red Lake …
The American Conference Institute (“ACI”), together with the Council for Responsible Nutrition, are sponsoring ACI’s Annual Legal, Regulatory, and Compliance Forum on Dietary Supplements. The virtual conference is scheduled to take place on June 23-24, 2020. This “must-attend” event for legal, regulatory, and compliance stakeholders in …
Much to our delight, the Orange Book is getting quite a bit of attention from FDA in 2020. And why not?!? After all, the Orange Book is celebrating its 40th anniversary this year. There was even a special “BPCIA Orange Book Transition Edition” published in …
Two new guidances, both issued by FDA on May 11, 2020, focus on drugs and biological products proposed for use against COVID-19. The first is entitled COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products (the “Pre-IND …
Last week, FDA announced availability of a guidance that would temporarily provide flexibility regarding certain labeling requirements during (and possibly after) the COVID-19 pandemic. This is the fifth time since the start of the pandemic that FDA announced flexibility regarding labeling regulations for foods. The temporary …
Hyman, Phelps & McNamara, P.C. seeks to add a 1st to 4th year associate to its enforcement and litigation team. Our team investigates and defends against threatened enforcement actions by government prosecutors and regulators, including the FDA and DEA. Types of matters include: Representing clients in …
The U.S. Government Accountability Office (GAO) released a report titled “Food Safety: FDA and USDA Could Strengthen Existing Efforts to Prepare for Oversight of Cell-Cultured Meat.” This report was requested by Rep. Rosa DeLauro (D-Conn.), and concerns the federal oversight of cell-cultured (or cell-based) meat, …
Now that most of the country has been in lockdown for about two months, everyone is undoubtedly aware that COVID-19 has been declared an “official” public health emergency. In addition to the official declaration in January, HHS issued an additional and separate declaration – called …
The Pharmaceutical Manufacturing Research Services (“PMRS”) appears to abide by the proverb “If at first you can’t succeed, try try again.” After several denied Citizen Petitions, striking out in the Eastern District of Pennsylvania, and bringing then dismissing another suit against FDA in that same …
These are unsettling times as COVID-19 impacts our personal and professional lives, as well as those that we love. During these unprecedented times, Hyman, Phelps & McNamara, P.C. is pleased to bring you the next installment of the FDA Law Alert. This is the fifth …
On Wednesday, May 6, 2020, from 12:00pm-1:00pm (Eastern) the Maryland/Israel Development Center will hold a webinar, “Israeli COVID-19 Vaccine Developments.” The event will discuss how Israel has mobilized its scientific and technological talents to address COVID-19, and will feature the following speakers: Yaky Yanai, CEO of …
As unfortunately happens during every national disaster or emergency, unscrupulous individuals and companies see an opportunity to make money. A lot of it. When that happens, there are always immediate calls to prosecute individuals and companies for “price gouging” certain products and taking advantage of …
Since HHS declared a public health emergency caused by COVID-19 in February 2020, there has been an overwhelming response to develop and market products to treat or mitigate the effects of the virus. Unfortunately, bad apples still are out there preying upon consumer fears and …
We’re a little late to the party on this one (let’s just blame it on social distancing), but, after 10 years in the making, Transition Day has finally come and gone for protein products. For the uninitiated, on March 23, 2020, all products approved as …
