On Oct. 23, 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance in the form of questions and answers (Q&A) regarding manufacturers’ (Firms) dissemination of scientific and medical information on unapproved...more
Since mid-2022, the macro acquisition environment has faced the challenges of inflation and increasing interest rates, among a variety of other headwinds. Global deal flow is down from its 2021 peak. Yet, as this white paper...more
The U.S. Food and Drug Administration (FDA) is accepting comment until June 6, 2022, on its proposed rule, National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers....more
In January 2022, the U.S. Food and Drug Administration (FDA) released finalized guidance on premarket pathways for combination products.
While the guidance is not binding, it provides industry participants with valuable...more
In episode three of McGuireWoods’ Edible Bites video series, the newly released U.S. Food and Drug Administration compounding pharmacy memorandum of understanding is hashed out, including discussion on key provisions and...more
On July 18, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for sample pooling of specimens when using the SARS-CoV-2 rRT-PCR diagnostic test from Quest Diagnostics....more
Blasting off into summer, the U.S. Food and Drug Administration (FDA) is soliciting feedback from the industry about what they would want to see added to the Orange Book. FDA’s Orange Book (also known by its less-used formal...more
COVID-19 has forced the healthcare system to adapt to a unique set of circumstances. As reported in prior McGuireWoods updates, a number of state and federal developments have affected the practice of pharmacy during the...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
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
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
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
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 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
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
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
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