The development and growth of the generic pharmaceutical industry over the past 30 years has come as a response to rising healthcare costs. Generic pharmaceuticals, which are carefully manufactured formulations of the original, patented "brand name" products, help to make American healthcare more affordable.
For more information on generic drugs, visit the FDA's Office of Generic Drugs webpage.
Answer: Yes, Generic pharmaceutical manufacturers must provide to the FDA that their version of the drug:
Answer: Generic manufacturers are able to sell their product for lower prices not because the products are of lesser quality, but because generic manufacturers generally do not have significant expenses to recoup, such as research and development costs, since generics are the not new drugs:
Answer: Yes. Generic medicines have to be safe and effective to be approved by the FDA. The FDA also requires generic drug manufacturers to meet the same batch-to-batch requirements for strength, purity, and quality as the original manufacturer; and follow the same strict "Good Manufacturing Practices" rules.
Answer: Yes. When a generic drug product is approved, it has met rigorous standards established by the FDA with respect to identity, strength, quality, purity and potency. Some variability can and does occur during manufacturing, for both brand-name and generic drugs. When a drug, generic or brand name, is mass produced, very small variations in purity, size, strength and other parameters are permitted. The FDA puts limits on how much variability in composition or performance of a drug is acceptable.