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Fdaguidance.net » FDA Guidance

About FDA Guidance Net We freely share and provide healthcare, regulatory and medical information announced, issued or published by the United States Food and Drug Administration (US FDA), striving to help the industry, consumers and the public get better informed with practical information.


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Learn and download here from FDA Guidance.Net Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) LICENSURE OF BIOLOGICAL PRODUCTS AS BIOSIMILAR OR INTERCHANGEABLE.—Section 351 of the Public Health Service Act (PHSA) (42 U.S.C. 262)


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Fdaguidance.net » Drug Guidances - FDA Regulatory Information

What Is FDA Guidance? Guidance documents represent the Agency's current thinking on a particular subject. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute,


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