SQA

FEBRUARY 26, 2024

The glossary was originally published in 2014 and has been used to define excipient terms and acronyms commonly found in IPEC guides. PCPC provided feedback to the FDA on the development of an efficient electronic submission program (Cosmetics Direct) and recognizes that the FDA’s development of Cosmetics Direct is ongoing.

FDA 52

FDA Compliance COVID-19 Public Health 52

Bill of Health

MAY 28, 2024

Since 2014, Congress has passed spending amendments that limit the use of federal funds for enforcement against state-compliant medical marijuana programs. Schedule 3 drugs must be approved by the Food and Drug Administration (FDA,) prescribed by a doctor, and distributed by a pharmacy. From 2009-2018, several U.S.

FDA 214

FDA Bioethics Compliance Telemedicine 214

Drug & Device Law

FEBRUARY 29, 2024

Not to mention, it is a powerful defense for our clients in product liability matters because it can foreclose liability and plaintiffs’ use of tort lawsuits (invariably creatures of state law origin) to impose requirements on medical devices or pharmaceuticals that the federal FDA did not. What could be better than preemption? United Bhd.

COVID-19 59

COVID-19 Informed Consent FDA Governance 59

Drug & Device Law

MAY 26, 2023

We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. A hundred years later, we detailed three rounds of litigation over Massachusetts’ serial efforts to ban, or at least substantially limit, the use of FDA-approved pain medications.

FDA 59

FDA Licensing Doctors Governance 59

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution. . .

FDA 59

FDA Licensing Hospitals Governance 59

Drug & Device Law

FEBRUARY 2, 2023

2014) (applying Texas law). 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. 3d 322, 326 (5th Cir. manufacturer, . . manufacturer, . .

FDA 59

FDA Licensing Fraud 59

Drug & Device Law

OCTOBER 27, 2022

640.65, an FDA biologics regulation that requires entities that collect blood via a particular method to establish “donor identification system[s]” that “positively identifies each donor and relates such donor directly to his blood and its components as well as to his accumulated records and laboratory data.”. 3d 467, 477 (E.D.

FDA 59

FDA Licensing Compliance 59

Drug & Device Law

JUNE 2, 2022

2012), addressed a challenge to the application of Idaho’s Pain-Capable Unborn Child Protection Act to criminalize the use of an FDA-approved abortifacient medication obtained through an internet prescription and mailed to the plaintiff from out of state. 2014), that the Arizona statute was likely unconstitutional. Hiedeman, 694 F.3d

FDA 127

FDA Licensing 127

Drug & Device Law

MARCH 7, 2022

Gloucester County , 2014 WL 1599499, at *3 (D.N.J. April 21, 2014). These allegations lack any contention or inference that [defendant] withheld or misrepresented information to the FDA. . ., It does not give him license to evade the less rigid ? It does not, however, give a plaintiff “license to evade the less rigid ?

Fraud 59

Fraud FDA Licensing Pharmaceutical Industry 59