FDA Law Blog

MARCH 21, 2024

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. As the new law unfolds—and as state laws regarding ingredients and packaging, as well as laws regarding environmental claims continue to affect the cosmetics and personal care industries—the topics covered at the conference have never been more relevant.

Cosmetics 64

Cosmetics Production Compliance Regulation 64

Camargo

NOVEMBER 15, 2021

The 21 st Century Cures Act generated a good deal of excitement and interest when it added a section called “ Utilizing Real World Evidence ” to the Food, Drug, and Cosmetic Act (Section 505F). The guidance also contains some useful information, despite the limitations described above. Manager, Regulatory Compliance.

Development 187

Development Manufacturing Production Packaging 187

FDA Law Blog

FEBRUARY 21, 2024

Both ISO 13485 and ISO 9000 contain terms and definitions that are referenced within Part 820. Subpart B – Supplemental Provisions Subpart B – Supplemental Provisions, adds requirements related to control of records (new § 820.35) and device labeling and packaging controls (new § 820.45). Revised § 820.3

Regulation 59

Regulation Manufacturing Packaging Packaging 59

FDA Law Blog

MARCH 6, 2022

The gap between QSR requirements and ISO standards has created confusion for companies that focused compliance only on ISO certification. The proposed QMSR includes sections on control of records and device labeling and packaging controls. See, e.g. , FDA Warning Letter to San Up S.A.

Regulation 52

Regulation Compliance Manufacturing Packaging 52

FDA Law Blog

JUNE 12, 2023

The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled. By Riëtte van Laack — FDA regulates pet food similar to other animal foods.

Regulation 45

Regulation Production Cosmetics Sales 45