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Food & Drug Administration - Office of Generic Drugs - Table #20
Contact: Patricia Littleton
7519 Standish Pl.
Rockville, Maryland 20855 USA
genericdrugs@fda.hhs.gov
www.fda.gov
Tel: +1-240-276-9310
Fax: +1-240-276-9327
Generic drugs are important options that allow greater access to health care for all Americans. They are copies of brand-name drugs and are the same as those brand name drugs in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Health care professionals and consumers can be assured that FDA approved generic drug products have met the same rigid standards as the innovator drug. All generic drugs approved by FDA have the same high quality, strength, purity and stability as brand-name drugs. And, the generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs. Congress passed the Generic Drug User Fee Amendments of 2012 (GDUFA), designed to speed access to safe and effective generic drugs to the public and reduce costs to industry. User fees are fees paid by industry to FDA to help the Agency ensure that Americans have timely access to safe, high-quality, affordable generic drugs. The passage of GDUFA represents a historic event, marking the first time the generic drug industry will provide such funding to FDA. With the passing of GDUFA, we will be hiring multiple positions over the next 3 years

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