Regulatory Affairs Certification (RAC) Practice Exam

What does FDA require regarding the preclinical studies of a new drug?

1. Only studies of pharmacology are required.

2. No studies are needed if there is already an approved similar product.

3. Studies must demonstrate safety and efficacy before human trials begin.

4. Only safety studies are needed before human testing.

The correct answer is: Studies must demonstrate safety and efficacy before human trials begin.

The requirement from the FDA regarding preclinical studies for a new drug is that studies must demonstrate safety and efficacy before human trials can commence. This is essential to ensure that any potential risks to human subjects are identified and that there is a plausible basis for the drug's intended effects before it is administered to people. Preclinical studies typically involve both in vitro (test tube or culture dish) and in vivo (animal) testing and aim to assess the pharmacological properties, potential side effects, and toxicology of the drug candidate. Demonstrating both safety and efficacy through these studies provides a comprehensive overview that informs the risk-benefit analysis necessary for progressing to human trials. Successful completion of these studies allows researchers to submit an Investigational New Drug (IND) application to the FDA, which is a critical step in seeking approval to begin clinical trials. Looking at the other options: Only requiring pharmacology studies or only safety studies would not provide a complete assessment needed for human testing. Moreover, claiming that no studies are needed when a similar product is already approved undermines the unique safety and efficacy profile each new drug must demonstrate, regardless of similarities to existing products. Thus, ultimately, the emphasis on both safety and efficacy is pivotal to safeguarding public health in the drug approval process