Hot Topics in Food and Nutrition
The FDA Food Safety Modernization Act (FSMA)
Prior Notice of Imported Foods
Hazard Analysis & Critical Control Points (HACCP)
Nutrition Facts Label Programs
The Center for Biologics Evaluation and Research (CBER) regulates human gene therapy products -
The amount of gene-
C. Humphrey & Associates, P.A. assists clients with compliance with the regulation of human cellular and tissue-
Our FDA Attorneys and FDA consultants determine which regulations apply to their HCT/Ps, premarket reviews, establishment registration and listing of the HCT/Ps on the FDA website, preparation for establishment inspections, and the import and export of HCT/Ps. We have experience reviewing and compiling standard operating procedures for clients to ensure compliance with FDA regulations for donor screening and testing, Good Tissue Practices, labeling and tracking of HCT/Ps, record keeping, and adverse event reporting requirements. We also help clients with the promotion and advertising of their HCT/Ps and HCT/P services to ensure proper classification under the regulations.
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