Medical Research
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- Q What is the primary source of funding for new drug development?
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Major pharmaceutical and biotechnology companies are the primary source of research and development funding for new medicine development. They support research projects in their own laboratories as well as further development of molecules and... Full Answer
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- Q Does safety monitoring continue after a drug is approved by the FDA?
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The safety monitoring continues for medicines long after FDA approval has been granted. Manufacturers are required to notify FDA immediately of any potential issues or concerns about a particular medicine. They also must submit summary reports to... Full Answer
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- Q How good is the U.S. prescription drug safety record?
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Although there is always room for improvement in patient safety, the United States has the world's best drug safety record. The FDA conducts rigorous reviews of each drug during an approval process that spans 10 to 15 years. FDA regulators... Full Answer
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- Q How is drug safety established?
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Drug safety is established incrementally through all stages of the development process. It is assessed early in the process through a series of laboratory tests, animal tests, and then with very small numbers of volunteer patients. Only after... Full Answer
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- Q Why do we need to monitor drugs so closely after they receive FDA approval?
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No drug is 100% safe and effective for all patients. Every drug, whether it is over-the-counter or prescription, carries some risks or potential side effects, and sometimes these side effects don’t become known until after the medicine has... Full Answer
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- Q How is drug safety monitored?
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Pharmaceutical companies, the FDA, health care providers and patients all play important roles in monitoring drug safety. Once a new medicine is approved, the manufacturer is required to file safety reports with FDA every three months for three... Full Answer
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- Q What is the role of pharmaceutical companies in ensuring drug safety?
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The pharmaceutical industry has two major roles in managing the safety of medicines: 1) To collect, investigate and proactively evaluate information relating to side effects of medicines during the clinical trials phase. 2) To vigorously monitor... Full Answer
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- Q What is the FDA's role in drug safety?
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The FDA serves as a consumer watchdog—it makes sure that safe and effective drugs are available to improve the health of patients who need them. The FDA evaluates new drugs before they can be sold and ensures that prescription and... Full Answer
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- Q Are there ways to make drugs even safer?
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Pharmaceutical manufacturers are dedicated to educating the public about drug safety. In addition, the companies are committed to: 1) improve the adverse event reporting system to make it easier for patients and physicians to report issues; 2)... Full Answer
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- Q What is involved in preclinical testing of drugs?
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Once a drug candidate has been identified in the laboratory, it begins years of testing. It starts with lab and animal studies to evaluate its safety and demonstrate that it has biological activity against the disease target. Key... Full Answer
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