Drugs are rigorously tested before reaching pharmacy shelves.
The U.S. government's Food and Drug Administration, or FDA, is responsible for monitoring and regulating the approval of new drugs and food manufacturing and production processes. A specialized branch of the FDA, the Office of Testing and Research, is responsible for evaluating and certifying new prescription drugs.
Center for Drug Evaluation and Research
The FDA's Center for Drug Evaluation and Research, or CDER, is responsible for ensuring that new prescription medications are marketed in a way that is safe for drug users. The CDER is also responsible for both prescription and over-the-counter drugs by undertaking reviews of medications and post-marketing risk assessments. As a new drug is developed, the manufacturer applies for an Investigational New Drug, or IND, application from the FDA, which allows for the conducting of clinical trials. After clinical trials, a pharmacological company submits a new drug application, or NDA, in which the manufacturer submits the test results, showing the effectiveness of the drug, and its other evidence to the CDER. At CDER, teams of physicians, statisticians, chemists and pharmacologists review the NDA for approval or rejection.
Clinical Trials
After an IND is submitted, a drug company must wait 30 days before clinical trials can begin. During this time, the FDA can order a "clinical hold" if it finds problems with the new drug. Once clinical trials begin, human test subjects are used to see whether the drug is effective and what its potential side effects might be. The sponsor or manufacturer that submits the IND and conducts the clinical trials must adhere to specific regulations and guidelines to submit a proper study of the new drug in the NDA as well as to protect its human test subjects.
New Drug Application
Certain information is required from the clinical trial and the manufacturer to submit an NDA to the CDER. The NDA must include information including details on the manufacturing processes, stability and bioavailability data, analytical methods for different dosage forms, packaging and labeling of the drug and results from toxicological studies.
Approval
Approval by the FDA entails two main categories, including the safety and effectiveness of the new drug and the labeling of the drug for marketing purposes. During the IND and NDA applications, the manufacturer must show substantial evidence regarding the effectiveness of the new drug as well as its side effects through different toxicological studies. The specifics of the drug's labeling and marketing material must also be approved by the FDA, both for doctors and pharmacists as well as consumers.
Tags: clinical trials, effectiveness drug, Center Drug, Center Drug Evaluation, clinical trials, clinical trials begin
