SQA

OCTOBER 18, 2023

The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products. At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections.

FDA 40

FDA Compliance Licensing World Health 40

SQA

OCTOBER 18, 2023

At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections. FDA ensures that broad-spectrum sunscreens protect against both Ultraviolet A (UVA) and Ultraviolet B (UVB) radiation and are safe and effective. Understanding CDERs Risk-Based Site Selection Model.

FDA 40

FDA Compliance Licensing World Health 40

Bill of Health

AUGUST 29, 2022

2004) (“[T] the fundamental right to an opportunity for an education does not guarantee that a student cannot temporarily forfeit educational services through his own conduct. Comm’n of the States (March 2016), [link] (50 state survey on state constitutional rights to education). However, because Washington, D.C., 3d 868, 874 (Wyo.

COVID-19 Vaccine 130

COVID-19 Vaccine COVID-19 Informed Consent Governance 130

Hall Render

FEBRUARY 2, 2024

Inman College of Nursing FDA clears Collierville startup CircumFix’s medical device for surgery, marketing FTC opposes Novant Health’s $320M hospital deal with Community Health Systems HCA CFO to retire HCA nets $5.2B

Nursing Homes 40

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

Drug & Device Law

JANUARY 15, 2024

We have discussed how exclusion of FDA compliance in pelvic mesh cases, based on a false equivalence between preemption and evidentiary admissibility, has hampered the defense in that litigation. In state court, Creazzo remains binding precedent. 3d 1245 (N.J. at 354 (citations omitted). Blaw-Knox , 360 F.3d 3d 426, 431 n.3

Compliance 52

Compliance FDA Governance State Policy 52

Drug & Device Law

DECEMBER 4, 2023

CPAP II shrugs off plaintiffs’ repeated allegations that defendants “failed to apprise the FDA” of this or that, with the excuse that plaintiffs don’t really “rely” on them. Plaintiffs Legal Committee , 531 U.S. 341 (2001). 2023 WL 7019287, at *7. Bizarrely, in applying Buckman , CPAP II relies on a “presumption against preemption,” id.

Fraud 52

Fraud FDA Hospitals Doctors 52

Drug & Device Law

OCTOBER 23, 2023

312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. 2004); Sheetz v. 2004) (Posner, J.); Back in 2008, the United States Supreme Court held, in Riegel v. Medtronic, Inc. , 2006); Doe 1 v. North Central Behavioral Health System, Inc. ,

FDA 59

FDA Governance Nurses Hospitals 59

Drug & Device Law

MAY 4, 2023

2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. FDA approved the drug with its particular formulation and the manufacturer could not have changed the formulation on its own. As detailed here , the decision in Yates v. Ortho-McNeil-Janssen Pharms.,

FDA 64

FDA Fraud Compliance 64

Drug & Device Law

FEBRUARY 2, 2023

2004); and Hackett v. Texas, unlike most states, enforces a strong statutory presumption that prescription medical product warnings complying with FDA requirements imposed by “pre-market approval or licensing of the product” are adequate as a matter of law. March 4, 2005), rev’d on other grounds , 462 F.3d 3d 364 (5th Cir. & Rem.

FDA 59

FDA Licensing Fraud 59

Drug & Device Law

JUNE 6, 2022

The prescriber] provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings, as well as the information found in [defendant’s] updated. . . 2004) (no causation where prescriber “continues to prescribe [similar] medication. . . Bayer HealthCare Pharmaceuticals, Inc. ,

FDA 59

FDA Doctors Malpractice Informed Consent 59

Drug & Device Law

MAY 5, 2022

2022), a short decision that came out the right way, but did so based on a problematic statute that creates a rebuttal presumption that warning labels approved by the FDA are adequate as a matter of state law. Stated differently, the rebuttal provision makes allegations and evidence of fraud on the FDA a prerequisite to state-law liability.

Compliance 52

Compliance FDA Fraud 52