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Global Process for Generic Drug Approval
Corresponding Author(s) : K.Sandhya
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 11 No. 4 (2023): 2023 Volume -11 - Issue 4
Abstract
Drug approval standards in the United States are considered by many to be the most demanding in the world. Developing a new drug requires great amount of research work in discovery, development, preclinical research, clinical research. Reviewers in regulatory agencies throughout the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This work focuses on drug approval process in different countries like USA, Europe and India.
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- Generic Drug Facts, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 2017-10-06, retrieved 2017-11-11
- "What's the difference between brand-name and generic prescription drugs?". Scientific American. Retrieved 2017-11-11.
- "Food & Drug Administration, Generic Drugs: Questions and Answers". Food and Drug Administration. January 12, 2010. Retrieved 2010-02-03.
- U.S. Food and Drug Administration. "Biosimilar and Interchangeable Products". www.fda.gov. Retrieved 5 May 2018.
- 35 U.S.C. § 154(a)(2)
- "Pediatric Research Equity Act of 2007" (PDF).
- Jump up to:a b c "An insider's view of generic-drug pricing". Los Angeles Times. March 25, 2013.
- Jump up to:a "Generic Drug Savings in the U.S" (PDF). Washington, DC: Generic Pharmaceutical Association (GPhA). 2015. Retrieved 16 June 2016.
- FDA. Food and drug administration. Retrieved 21 May 2018.
- FDA White Paper: Generic Drug Prices in the US Are Lower Than Drug Prices in Canada". FDA. 6.US Food and Drug Administration, Office of Planning. Retrieved 21 May 2018.
- Branded Generics: Misunderstood, but Lucrative". Pharmacy Times. 1 October 2008. Retrieved 21 May 2018.
- Big Pharma Embraces Branded Generics". Seeking Alpha. Seeking alpha. 2010-10-31. Retrieved 21 May 2018.
References
Generic Drug Facts, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 2017-10-06, retrieved 2017-11-11
"What's the difference between brand-name and generic prescription drugs?". Scientific American. Retrieved 2017-11-11.
"Food & Drug Administration, Generic Drugs: Questions and Answers". Food and Drug Administration. January 12, 2010. Retrieved 2010-02-03.
U.S. Food and Drug Administration. "Biosimilar and Interchangeable Products". www.fda.gov. Retrieved 5 May 2018.
35 U.S.C. § 154(a)(2)
"Pediatric Research Equity Act of 2007" (PDF).
Jump up to:a b c "An insider's view of generic-drug pricing". Los Angeles Times. March 25, 2013.
Jump up to:a "Generic Drug Savings in the U.S" (PDF). Washington, DC: Generic Pharmaceutical Association (GPhA). 2015. Retrieved 16 June 2016.
FDA. Food and drug administration. Retrieved 21 May 2018.
FDA White Paper: Generic Drug Prices in the US Are Lower Than Drug Prices in Canada". FDA. 6.US Food and Drug Administration, Office of Planning. Retrieved 21 May 2018.
Branded Generics: Misunderstood, but Lucrative". Pharmacy Times. 1 October 2008. Retrieved 21 May 2018.
Big Pharma Embraces Branded Generics". Seeking Alpha. Seeking alpha. 2010-10-31. Retrieved 21 May 2018.