Health Law Advisor

JANUARY 31, 2023

The Food and Drug Administration (FDA) recently issued both draft and final guidance regarding food allergen labeling requirements. FDA does note that if such measures cannot eliminate cross-contact, manufacturers will often use advisory statements to alert allergic consumers to the potential for cross-contact.

FDA 52

FDA 52

SQA

DECEMBER 16, 2022

The CMDE published additional documents (link in Chinese) that outline the recommended paths for clinical evaluation of certain devices under select sub-categories of the Medical Device Classification Catalog. This proposal builds upon the existing legal framework, which came into force in 2002 for blood and 2004 for tissues and cells.

FDA 40

FDA Compliance COVID-19 Licensing 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