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.
Advarra
SEPTEMBER 8, 2022
This applies to electronic data and signatures submitted under records requirements under other regulations such as: Federal Food, Drug, and Cosmetic Act. After platform review, if a decision is made to validate, staff should generate documentation to ensure Part 11 compliance. Public Health Service Act.
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FDA Law Blog
AUGUST 27, 2023
The compliance policies described in the Guidance focus on the requirement that, beginning November 27, 2023, all trading partners generally will be required to use electronic-based approaches to meet the enhanced drug distribution security requirements set forth in in FDCA section 582(g)(1) (Enhanced Drug Distribution Security).
FDA Law Blog
NOVEMBER 16, 2021
Baumhardt advises clients on complaint handling, MDRs, Quality System Regulation compliance and enforcement matters. She has also held positions in regulatory affairs, clinical affairs, quality assurance, and compliance at Mallinckrodt Pharmaceuticals, GE Healthcare, and Abbott Laboratories. In the post-market area, Ms.
Cloudbyz
MAY 24, 2023
The trials span several categories of consumer products such as cosmetics, personal care products, nutrition supplements, food, beverages, and consumer health products. This includes trial design, participant recruitment, data collection and analysis, and regulatory compliance.
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). Batch steps include filter drying, milling, and packaging. Manager, Regulatory Compliance. Co-Authors: Bill Stoltman, JD. Jenny Fielder.
Cloudbyz
AUGUST 9, 2023
Integrated Compliance and Governance With stringent regulations governing clinical trials, compliance is of utmost importance. A unified platform can incorporate compliance guidelines and ensure that all processes align with regulatory standards.
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