Hall Render

JUNE 14, 2024

NATIONAL AHA Comments on CMS’ Inpatient Payment Proposal for FY 2025 AHA urges CMS to make Transforming Episode Accountability Model voluntary AMA adopts new policy to create equity in clinical trials and research DOJ loses bid to toss Humana Medicare Advantage case Drug shortages hit highest number since 2001, impacting patients, hospitals and pharmacies (..)

US Department of Health and Human Services 40

US Department of Health and Human Services Nursing Homes Nurses Hospitals 40

Drug & Device Law

JANUARY 4, 2024

341 (2001), and the exclusivity Buckman recognized of FDA authority over approval of the products it regulates also provide grounds for implied conflict preemption those the Complaint’s allegations. 247d-6d(b)(8). Plaintiffs Legal Committee , 531 U.S.

COVID-19 Vaccine 59

COVID-19 Vaccine COVID-19 FDA Public Health 59

Drug & Device Law

NOVEMBER 9, 2023

341 (2001)), calls “off-label use,” so we go with the majority naming convention. What the FDA calls, rather ponderously, “unapproved uses of approved/cleared medical products,” everybody else in the world (including the Supreme Court in Buckman Co. Plaintiffs Legal Committee , 531 U.S.

FDA 64

FDA Health Insurance Nurses Medicare 64

Drug & Device Law

JULY 31, 2023

2001); Isham v. 2001), relied on these other statutes to hold that a road could not be a “product”). 2001) (applying Illinois law); Serpico v. However, licensed software can be a UCC sale of “goods.” Huntington Ingalls Inc. , 3d 1170, 1173 (9th Cir. 2016) (citations omitted). Accord Stark v. 371, 377 (6th Cir.

Governance 52

Governance Payment Systems Hospitals Licensing 52

Drug & Device Law

FEBRUARY 20, 2023

Without an FDA license to produce another design, [defendant] was legally prohibited from distributing either [alternative design advocated by plaintiffs] at the time [plaintiff] received her vaccinations. 151, 163-68 (2001)) (lengthy discussion of FDA regulatory process omitted). Wyeth Laboratories, Inc. , 2d 397 (6th Cir.

FDA 59

FDA Licensing Hospitals Governance 59

Drug & Device Law

OCTOBER 27, 2022

341 (2001), the U.S. From this, the court concluded the defendants could “comply with both federal and Illinois law by obtaining proof of identity and establishing a donor identification system using photographic identification, a valid driver’s license, or any other non-biometric means.” 2d 808, 812 (E.D. 2013); Heisner v.

FDA 59

FDA Licensing Compliance 59

Drug & Device Law

SEPTEMBER 29, 2022

Before a biologic may be marketed, the manufacturer must obtain a license from the FDA. Plaintiff received the biologic just months after it had been licensed by the FDA. 341 (2001). In the course of denying the motion, the court misconstrued the law at least once and possibly twice. See 42 U.S.C. § See 21 C.F.R.

FDA 59

FDA Licensing Fraud 59

Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . . . 2001), aff’d , 358 F.3d Stryker Co. , 3d 568, 576-77 (6th Cir. Parke, Davis & Co. ,

Doctors 59

Doctors Licensing Informed Consent Hospitals 59