Fda

• The aim of the FDA is to protect public health in the USA.
• Tasks:
• Control of safety and efficacy of human and veterinary drugs, biological products, cosmetics, medical devices, food and radiation emitting devices. This applies to products manufactured in the USA as well as to imported products.
• Improving public health by introducing new drugs.
• Regular evaluation of new drugs or therapy options.

The FDA has a decisive role in international studies, especially in registration studies initiated in the USA, as these are based on US law.

Furthermore, the FDA also conducts inspections outside the USA and only accepts studies if the studies comply with all its regulations. The FDA has established uniform criteria with Japan and Europe within the framework of the International Conference on Harmonisation (ICH), although most of the criteria of US federal law have been implemented. When planning studies, it must therefore be ensured, for example, that the database systems are FDA-compliant and that the study is designed in accordance with FDA regulations.

An IND (Investigational New Drug) procedure must be initiated before the start of a clinical trial in the USA or with the participation of the USA. In this procedure, all preclinical documents are evaluated by the FDA. Only if there is no objection from the FDA within 60 days may the study begin.

1. Website: www.fda.gov
2. The FDA approves drugs for colorectal cancer, lung cancer. FDA Consumption 41: 5