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. 26 of 2014. International Society for Pharmaceutical Engineering (ISPE). CMDE Announcement No. 21 Medical Software.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

MAY 24, 2023

2022 Recap & 2023 Outlook: China Pharmaceutical Regulatory Updates, 28 February 2023 In 2022, China issued and implemented a series of drug regulations, including new rules for marketing authorization holders to manage drug quality and guidelines for pharmacovigilance inspections.

FDA 40

FDA Licensing Governance Compliance 40

SQA

FEBRUARY 26, 2024

The products had been improperly regularized in ANVISA as cosmetics since they are indicated for injectable use, a form that is not authorized for this category of product. The purpose of the note is to clarify that products for invasive aesthetic treatments cannot be regularized in the category of cosmetics.

FDA 52

FDA Compliance COVID-19 Public Health 52

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. Janssen Pharmaceuticals, Inc. , Coffing Hoist Division , 528 A.2d 2d 590 (Pa. Omega Flex, Inc. , 3d 328 (Pa. 3d 1245 (N.J. Sanchez , 716 A.2d

Compliance 52

Compliance FDA Governance State Policy 52