What are the requirements for the approval of drugs?

The requirements for drug approval in Oregon are in accordance with laws enforced by the Federal Drug Administration, as well as the state. In order to obtain approval, pharmaceutical companies must submit an Investigational New Drug application (IND) to the FDA. The IND provides the FDA with pre-clinical safety data and outlines the proposed clinical trials. Additionally, the FDA must first evaluate the safety and effectiveness of the drug and its potential to treat the disease it was designed to treat. If the FDA finds that the drug has the potential to be effective, it then allows the manufacturer to conduct clinical trials. Clinical trials are conducted in phases, each designed to test the safety and effectiveness of the drug in different populations. The first phase usually only involves a small group of people and focuses on safety. As the drug progresses through the clinical trial process, the number of people tested increases and tests for effectiveness are conducted. Once the clinical trials are complete, the pharmaceutical company submits a New Drug Application (NDA) to the FDA for final approval. The NDA must include all of the safety and effectiveness data that was collected during clinical trials. After the FDA evaluates the drug and demonstrates that it meets their standards, it approves the drug and it can be used by healthcare providers.

Related FAQs

What is the scope of the FDA’s authority in regulating pharmaceuticals?
What are the legal requirements for clinical trials?
What is the legal framework governing the importation of drugs?
What are the regulations governing the clinical trials of drugs?
What is the law regarding the reporting of adverse drug reactions?
What are the legal requirements for the marketing of pharmaceuticals?
What are the regulations pertaining to the production of pharmaceuticals?
What is the law regarding the manufacture of unapproved drugs?
What are the restrictions regarding the labeling of drugs?
What is the difference between ethical and clinical pharmaceuticals?

What are the requirements for the approval of drugs?

Related FAQs

Related Blog Posts