U.S. Food and Drug Administration (FDA)
(องค์การอาหารและยาแห่งสหรัฐอเมริกา (องค์การอาหารและยา))
Definition
U.S. Food and Drug Administration (FDA) (องค์การอาหารและยาแห่งสหรัฐอเมริกา (องค์การอาหารและยา)) Hard Skill
The U.S. Food and Drug Administration (FDA) is a federal agency responsible for protecting public health by regulating food safety, pharmaceuticals, medical devices, cosmetics, and other related products to ensure they meet safety and efficacy standards.
Expertise Level
Level 1
Basic
1. Understands the general role and purpose of the FDA.
2. Familiar with basic FDA regulations related to food and drug safety.
3. Can recognize the importance of FDA approval in product safety.
Level 2
Intermediate
1. Able to interpret and apply specific FDA regulations to relevant products.
2. Familiar with the FDA approval processes and documentation requirements.
3. Can identify compliance issues and understand FDA inspection procedures.
Level 3
Advanced
1. Can lead regulatory strategy and ensure full FDA compliance for product development.
2. Expert in FDA submission processes including New Drug Applications (NDA) and Food Facility Registration.
3. Able to manage FDA audits and effectively communicate with FDA officials.
