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The U.S. Food and Drug Administration (FDA) recently released a draft guidance document regarding transdermal and topical delivery systems, outlining the agency’s thoughts on process and product development.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
Cannabidiol (CBD) products increasingly are showing up in the mainstream market and taking many forms, including CBD-infused beverages, chocolates, and even beauty products. CBD, a plant-based compound naturally occurring in...more
In December 2018, Congress made significant changes to the Farm Bill, which legalizes industrial hemp. It also removes hemp-derived products such as cannabidiol (CBD) from Schedule I status under the Controlled Substances...more
U.S. Department of Health and Human Services Secretary Alex Azar announced this month the publication of a Final Rule from the Centers for Medicare & Medicaid Services (CMS) that will require television advertisements for...more
The next in our series of posts sharing key takeaways from panels at the Healthcare & Life Sciences Private Equity and Lending Conference discusses dermatology investing. It is authored by our colleagues Royce DuBiner,...more
The next in our series of posts sharing key takeaways from panels at the Healthcare & Life Sciences Private Equity and Lending Conference focuses on investing in surgical specialty practices.
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