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Tag: gdufa

First Generic Drug Approvals | FDA

January 11, 2020 Blogger

Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides…

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Posted in: Uncategorized Filed under: approvals, FDA, gdufa

FDA In Brief: New analysis highlights link between generic drug competition and lower drug prices, underscores importance of FDA efforts to spur generic drug development and market entry

December 13, 2019 Blogger

FDA In Brief: New analysis highlights link between generic drug competition and lower drug prices, underscores importance of FDA efforts…

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Posted in: Health Technology Filed under: FDA, gdufa, RLD

FDA Updates List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic

Blogger

FDA Updates List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic — Read on s2027422842.t.en25.com/e/es

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Posted in: Uncategorized Filed under: approvals, FDA, gdufa

First Generic Drug Approvals | FDA

October 1, 2019 Blogger

Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides…

Continue Reading →

Posted in: Uncategorized Filed under: FDA, gdufa

FDA updates list of inquiries from prospective generic drug applicants about RLD access

September 19, 2019 Blogger

FDA updates list of inquiries from prospective generic drug applicants about RLD access — Read on s2027422842.t.en25.com/e/es

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Posted in: RLD Filed under: gdufa, RLD

Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications | FDA

August 28, 2019 Blogger

The FDA is issuing an update regarding the ongoing efforts to resolve safety issues with ARB medications. — Read on…

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Posted in: Uncategorized Filed under: gdufa

Federal Register :: Generic Drug User Fee Rates for Fiscal Year 2020

August 20, 2019 Blogger

The Federal Food, Drug, and Cosmetic Act (FD&C Act or statute), as amended by the Generic Drug User Fee Amendments…

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Posted in: Regulatory Fees Filed under: gdufa

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