Compliance Cosmetics Drugs Packaging 
Advarra
SEPTEMBER 8, 2022
Computer systems used for clinical trials fall under Food and Drug Administration (FDA) 21 CFR Part 11. This applies to electronic data and signatures submitted under records requirements under other regulations such as: Federal Food, Drug, and Cosmetic Act. What is 21 CFR Part 11? Public Health Service Act.
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).
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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 FDA recently published the ICH’s Harmonised Guideline Q13, titled “ Continuous Manufacturing of Drug Substances and Drug Products.”
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.
FDA Law Blog
SEPTEMBER 6, 2023
Farquhar — A drug manufacturer’s bad post-inspection grade from the U.S. Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. By Douglas B.
Cloudbyz
MAY 24, 2023
Understanding Clinical Research in Consumer Products Companies Unlike the pharmaceutical industry, where clinical trials are inherently a part of drug discovery and approval, the consumer products industry has seen a growing emphasis on clinical research relatively recently.
Cloudbyz
OCTOBER 19, 2023
Clinical trials are the backbone of drug development, and managing these trials efficiently is paramount. Regulatory Compliance: Streamlining processes aids in meeting stringent regulatory requirements and maintaining data integrity. Site Selection: Data-driven site selection improves trial success rates and reduces resource wastage.
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