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Guidance and regulatory information on Food and Dietary Supplements; includes guidance for industry as well as manufacturing processes, food facility registration, HACCP, retail food protection...
- Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)
Submitting Form FDA 2541 (Food Canning Establishment...
- Food Safety Modernization Act (FSMA)
The FDA Food Safety Modernization Act (FSMA) is transforming...
- Food Imports & Exports
Under provisions of the U.S. law contained in the U.S....
- Registration of Food Facilities and Other Submissions
The FDA Food Safety Modernization Act (FSMA), enacted on...
- Retail Food Protection
FDA assists regulatory agencies and the industries they...
- Hazard Analysis Critical Control Point (HACCP)
HACCP systems addresse food safety through the analysis and...
- Current Good Manufacturing Practices (CGMPs) for Food and Dietary Supplements
In 21 CFR Part 117, FDA established a CGMP regulation as...
- Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)
FDA regulates all foods and food ingredients introduced into or offered for sale in interstate commerce, with the exception of meat, poultry, and certain processed egg products regulated by the...
4 mar 2022 · The name-brand approval process consists of five steps — discovery/concept, preclinical research, clinical research, FDA review, and FDA post-market safety monitoring. The company must test the product on animals before humans to ensure safety.
24 lis 2023 · The application process involves identifying the correct FDA division, preparing the label according to FDA guidelines, compiling necessary documentation, utilizing FDA’s electronic submission systems, submitting the label for review, and responding to FDA feedback.
15 sty 2020 · The Food and Drug Administration (FDA) is responsible for the regulation of the pharmaceutical industry in the interest of protecting public health. The aim of this review was to outline the evolution and current role of the FDA in the development and approval of new drugs.
This first part of a 2-part series is intended to provide an overview of the steps in bringing a drug through the process of clinical trials and FDA approval. The second part of this series will discuss the process of obtaining approval to study devices, which have their own unique pathway.
1 lut 2009 · This article reviews the basic components of the FDA’s decision-making process for evaluating the safety of new food additives, and identifies characteristics of this process that are central to assuring that FDA’s decisions are marked by scientific rigor and high integrity, and can continue to be relied on by consumers.