ProRelix Research

DECEMBER 28, 2023

Considering the crucial role that the information generated from clinical trials play in the approval of new drugs, biological, and medical devices, it is only logical that the data garnered […] The post Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management appeared first on ProRelix Research.

FDA Compliance 52

FDA Compliance Clinical Trials Compliance Trials 52

FDA Law Blog: Biosimilars

JANUARY 1, 2024

Maybe that’s also why FDA last week publicized the highest number of important Warning Letters of the year (compared with prior releases in 2023). Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials.

FDA 59

FDA Clinical Trials FDA Compliance Production 59

Drug & Device Law

MARCH 19, 2024

TBI was the first nationwide (or close to it) analysis of whether a given jurisdiction permitted, under state law, a “warning”-based cause of action against a manufacturer of an FDA-regulated prescription drug or medical device for allegedly failing to report adverse events to the FDA.

FDA 52

FDA FDA Compliance Trials FDA Approval 52

Drug & Device Law

JANUARY 25, 2024

In Watson , even though it was about FTC regulation, the Court took a shot at the notion that drug and device companies might try to remove their myriad product liability cases based on this statute if interpreted to cover mere regulation. 308 (2005), which comes up not infrequently in drug and device product liability cases.

Production 52

Production Regulations FDA Compliance Compliance 52

Drug & Device Law

JANUARY 15, 2024

2006) – a precedential holding that the same Pennsylvania rule barring strict liability claims against prescription drugs also applied to prescription medical devices − should not be followed because the plaintiffs in Creazzo were supposedly “pro se.” Medtronic, Inc. , but see Hahn v. Richter , 543 Pa. 558, 673 A.2d Tincher , 104 A.3d

Compliance 52

Compliance Government Production FDA Compliance 52

Drug & Device Law

JULY 26, 2023

470 (1996), outside of the (now obsolete) presumption against preemption context in which it occurred − making FDA compliance an all-or-nothing proposition in medical device cases. which caused the claimant’s harm was subject to premarket approval or licensure by the federal Food and Drug Administration. . . Lohr , 518 U.S.

Compliance 52

Compliance FDA Compliance FDA Clinical Trials 52