Consider this an addendum to the "Adequate Warnings Should be Enough" post that Bexis wrote back in February. What makes a warning "adequate"?
Under the orders, health care regulators are to address alleged kickbacks, access to "life-saving medications," drug importation, and "most-favored-nation" proposal.
This year has seen a lot – and most of it would not fall into the positive category. The pandemic; severe wildfires in the U.S. and Australia
Seyfarth Shaw LLP
On October 22, 2020, the U.S. Food and Drug Administration (FDA) formally approved Veklury (remdesivir) as a treatment of COVID-19. Veklury, an antiviral drug, is the first treatment approved...
We have a long, 50-state survey post entitled "Don't Forget About A Prescribing Physician's Failure To Read Warnings," about a subject as to which we feel strongly enough that we keep it updated on
It's a unique relationship based largely on knowledge and trust. Doctor's not only have to rely on their medical knowledge, but they need to apply that to their knowledge of the patient.
Arnold & Porter
On September 24, 2020, the HHS Secretary and the FDA issued a final rule implementing a provision of law allowing the commercial importation of certain prescription drugs from Canada through FDA-authorized, time-limited programs ...
Arnold & Porter
The numerous requirements to legally market a medical device, drug, biologic, or combination thereof in the United States are meant to reassure consumers that these medical products are safe and that the scope of their effectiveness is understood.
Gibson, Dunn & Crutcher
The False Claims Act (FCA) is well-known as one of the most powerful tools in the government's arsenal to combat fraud, waste and abuse anywhere government funds are implicated.
For the better part of a decade, Bexis has participated in the Food & Drug Law Institute's ("FDLI") annual Top Food and Drug Cases project.
Husch Blackwell LLP
It is important to note that the checklist is not an OSHA standard that establishes a basis for a fine or liability under the Occupational Safety and Health Act.
Cowan Liebowitz & Latman PC
Whether an ordinary purchaser would think so in the real world was not relevant to this trademark registrability analysis.
Proskauer Rose LLP
Plaintiffs alleged Parkay's "0 fat," "fat free," and "0 calories" claims therefore violated California's CLRA, UCL, and other state consumer protection laws.
Shearman & Sterling LLP
The Court held that plaintiffs failed to adequately allege an actionable misstatement or omission.
The Pelvic Mesh MDLs are now all but over, with all but a few stragglers either settled or remanded. But the specious logic used in that litigation to overturn decades of precedent that had...
Morrison & Foerster LLP
The House of Representatives recently passed a proposed bill that encourages treatments for rare pediatric diseases by prolonging the authority of Health and Human Services to issue priority review vouchers.
Holland & Knight
More than six months into the pandemic, there is still no easy or definitive answer to the question many retailers are asking about whether there is coverage
Holland & Knight
More than six months into the pandemic, there is still no easy or definitive answer to the question many retailers are asking about whether there is coverage for their business interruption losses related to COVID-19.
Duane Morris LLP
Earlier today, October 13, 2020, Gov. Phil Murphy announced plans to distribute $112 Million of the state's CARES Act money via grants to small businesses and struggling families.
Shipman & Goodwin LLP
Earlier this month, the Centers for Medicare and Medicaid Services (CMS) issued a reminder that its hospital price transparency final rule will become effective January 1, 2021...