Generic Drugs: Questions & Answers - FDA
A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and ...
Generic Drugs | FDA - U.S. Food and Drug Administration
Understanding generic drugs: Consumer-friendly information on the safe and effective use of generic drugs. Learn about the generic drug approval process, why generic drugs are usually less ...
Generic Drug Facts | FDA - U.S. Food and Drug Administration
2021年11月1日 · Visit the FDA Generic Drugs Program web page. Call 1-888-INFO-FDA 1 Association for Accessible Medicines. 2020 Generic Drug & Biosimilars Access & Savings in the U.S. Report .
Overview & Basics | FDA - U.S. Food and Drug Administration
The FDA 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 ...
Generic Drugs: What Everyone Should Know - FDA
According to the U.S. Food and Drug Administration (FDA), a generic drug is a copy that is identical to a brand-name drug in dosage, safety, strength, how it is taken, quality, performance and ...
FDA List of Authorized Generic Drugs | FDA - U.S. Food and Drug ...
2024年10月8日 · Section 505(t)(2) of the Act requires the list to contain authorized generic drugs included in an annual report submitted to the agency after January 1, 1999. Subsection 505(t)(3) defines an ...
Office of Generic Drugs 2023 Annual Report - FDA
2024年3月4日 · In 2023 generic drugs continued to play a critical role in the U.S. health care system allowing patients greater access to needed medicines. Generic drugs are generally lower cost than their brand ...
The Generic Drug Cluster Third Anniversary Reflection | FDA
2024年12月18日 · The Generic Drug Cluster has become an essential forum for international regulatory collaboration, bringing together agencies from around the world to share knowledge, address common challenges ...
Generic Drugs Forum (GDF) 2025 - 04/09/2025 | FDA
2024年12月20日 · Join us at the annual Generic Drugs Forum, a two-day event designed to facilitate the development and approval of safe, effective, and high-quality generic medicines. Generic Drugs Forum (GDF ...
FDA requires generic drugs to have the same active ingredient, strength, dosage form , and route of administration as the brand-name drug. The generic manufacturer must prove its drug is the same ...
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