A complete overhaul to the over-the-counter (OTC) drug system quietly rode its way into law with the Coronavirus Aid, Relief, and Economic Security Act or the CARES Act (H.R. 748), along with several other significant reform...more
The next in our series of posts sharing key takeaways from panels at the Healthcare & Life Sciences Private Equity and Lending Conference is authored by our colleagues Brian King and Royce DuBiner, and Kathy Contratto of RSM...more
As states brace themselves for an increasing number of novel coronavirus (COVID-19) cases, some pharmacy boards have relaxed regulations to ease burdens on pharmacy practitioners. Several states have declared a state of...more
The unprecedented public health emergency created by the novel coronavirus disease (COVID-19) has sparked action by state and federal regulators to ensure greater access to care, while simultaneously limiting the spread of...more
With the COVID-19 pandemic, the demand for hand sanitizer is extremely high, and the supply chain has not kept pace with that demand. In an effort to meet public need, several federal agencies, including the Food and Drug...more
Pharmacies nationwide are struggling to keep up with the demand for new prescriptions of hydroxychloroquine, chloroquine and mefloquine, the decades-old immunosuppressant and/or anti-inflammatory agents used for treating...more
As the nation battles shortages of novel coronavirus (COVID-19) testing kits, the U.S. Food and Drug Administration (FDA) has engaged its emergency use authorizations (EUA) process for unapproved products and uses to...more
In light of the urgent need for medical intervention during the coronavirus pandemic, the Department of Health and Human Services (HHS), through the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control...more
The COVID-19 pandemic has brought a cascade of statements from the U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS). Below are summaries of some of the more pertinent statements...more
Under the Public Readiness and Emergency Preparedness Act, the secretary of the U.S. Department of Health and Human Services can issue a declaration to provide immunity for individuals and entities from any liability arising...more
During the COVID-19 (coronavirus) national emergency, the Food and Drug Administration and U.S. Department of Agriculture continue to emphasize measures intended to keep the food supply safe....more
On Feb. 27, 2020, the U.S. Department of Agriculture (USDA) sent a flash update to the hemp industry announcing changes to some of the more complex aspects of the interim final rule for the establishment of a U.S. Domestic...more
Consumers may not think of salmon as a drug, but according to a recent opinion out of the Northern District of California, certain genetically modified (GMO) salmon qualify as drugs under the Food, Drug, and Cosmetic Act...more
On Jan. 15, the Subcommittee on Health of the Committee on Energy and Commerce held a legislative hearing to discuss cannabis policy. The focal point of most of the hearing was about research into marijuana, its extracts and...more
At last month’s MJBizCon, the premier gathering for cannabis and hemp industry experts, investors and industry professionals addressed cutting-edge issues in this rapidly expanding market....more
On Dec. 12, 2019, the U.S. House of Representatives passed HR 3, the Elijah Cummings Lower Drug Costs Now Act, which would allow the government to negotiate drug prices, among other reforms. Prior to HR 3 being considered on...more
On Dec. 11, 2019, the Developmental and Reproductive Toxicant Identification Committee of the California Office of Environmental Health Hazard Assessment will meet to discuss whether delta-9-tetrahydrocannabinol (THC) should...more
The U.S. Food and Drug Administration (FDA) recently released a draft guidance document regarding transdermal and topical delivery systems, outlining the agency’s thoughts on process and product development. FDA considers...more
On Oct. 24, 2019, in a joint statement from U.S. Food and Drug Administration (FDA) acting Commissioner Norman E. Sharpless, and the Center for Drug Evaluation and Research (CDER) Director Janet Woodcock, FDA announced that...more
On Oct. 28, 2019, the U.S. House of Representatives unanimously passed two bills that, if enacted, require public disclosure of the discounts drug companies provide to pharmacy benefit managers (PBMs)....more
In keeping with U.S. House Speaker Nancy Pelosi’s schedule for pushing H.R. 3, the Lower Drug Costs Now Act, through the House of Representatives, the three committees of jurisdiction held mark-ups and passed the proposal, as...more
The U.S. Food and Drug Administration recently announced it was exercising enforcement discretion for the required updated labeling of nutrition and supplement facts panels for six months following the first compliance...more
The U.S. Food and Drug Administration Center for Devices and Radiological Health (CDRH) recently released a list of guidance documents it intends to publish in fiscal year 2020, as well as a list of previously issued final...more
On Sept. 19, U.S. House Speaker Nancy Pelosi introduced legislation aimed at lowering the cost of prescription drugs. This article discusses the bill and notes key differences between Pelosi’s plan to address drug pricing,...more
On Sept. 10, 2019, the Federal Trade Commission (FTC) issued warning letters to three undisclosed companies regarding their marketing claims on cannabidiol (CBD) products. The FTC claimed that each company made various...more