Question

An ongoing clinical protocol at your site includes weekly blood draws to assess an exploratory endpoint. unfortunately, participants are not happy about visiting the clinic weekly, and they are considering dropping out. therefore, a protocol amendment is being prepared to remove the weekly blood draw. this change can be implemented:

Answer 1

An ongoing clinical protocol at your site includes weekly blood draws to assess an exploratory endpoint. Unfortunately, participants are not happy about visiting the clinic weekly, and they are considering dropping out. Therefore, a protocol amendment is being prepared to remove the weekly blood draw. This change can be implemented once the protocol is finalised and submitted to the FDA.

What is the FDA?

The Federal Food and Drugs Act, which was passed in 1906, led to the creation of the Food and Drug Administration (FDA). The organisation is divided into divisions, each of which is in charge of the majority of the organisation's responsibilities relating to food, medicines, cosmetics, animal food, nutritional supplements, medical devices, biological products, and blood products.

The FDA is renowned for its efforts to control the creation of new medications. All new pharmaceuticals must undergo clinical trials, according to regulations set down by the FDA. Before medicines may be offered to humans, pharmaceutical companies must put them through four stages of clinical testing.

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