Overview:

In the United States, 9 out of 10 prescriptions filled are for generic drugs. Increasing the availability of generic drugs helps to create competition in the marketplace, which then helps to make treatment more affordable and increases access to healthcare for more patients. 

Introduction:

Drug companies must submit an abbreviated new drug application (ANDA) to FDA for approval to market a generic drug that is the same as (or bioequivalent to) the brand product. FDA reviews the application to ensure drug companies have demonstrated that the generic medicine can be substituted for the brand-name medicine that it copies.

Office of Generic Drugs

The Office of Generic Drugs follows a rigorous review process to make sure that, compared to the brand-name (or innovator) medications, the proposed generic medications:

  • Contain the same active/key ingredient;
  • Have the same strength;
  • Use the same dosage form (for instance, a tablet, capsule, or liquid); and
  • Use the same route of administration (for instance, oral, topical, or injectable).

FDA’s review process ensures that generic medications perform the same way in the human body and have the same intended use as the name brand medication. 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. In addition, FDA inspects facilities to make certain the generic manufacturing, packaging, and testing sites pass the same quality standards as those of brand-name drugs.

BLOG: FDA Releases 2022 New User Fees

The US Food and Drug Administration (FDA) has published the user fees for 2022 that will be collected from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities.

More from the Office of Generic Drugs:

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Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.

GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations. 

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