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1-10 of 329 results for supplemental approvals

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Select article: Review of novel and supplemental approvals of the targeted cancer drugs by the Food and Drug Administration in 2021

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Review article

First published 2023-1

Review of novel and supplemental approvals of the targeted cancer drugs by the Food and Drug Administration in 2021

Esin Aysel Kandemir

Journal of Oncology Pharmacy Practice

Select article: An Analysis of Regulatory Review Times of Supplemental Indications for Already-Approved Drugs: 1989-1994

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Research article

First published 1996-4

An Analysis of Regulatory Review Times of Supplemental Indications for Already-Approved Drugs: 1989-1994

Joseph A. DiMasi, Jeffrey S. Brown, Louis Lasagna

Therapeutic Innovation & Regulatory Science

Select article: Supplemental Applications Proposing Labeling Changes for Approved Drugs,Biologics,and Medical Devices [excerpts]

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Research article

First published 2008-04

Supplemental Applications Proposing Labeling Changes for Approved Drugs,Biologics,and Medical Devices [excerpts]

Biotechnology Law Report

Select article: Applicability of Selective Data Collection to Cancer Clinical Studies for Supplemental Marketing Approvals

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Research article

First published 2016-7

Applicability of Selective Data Collection to Cancer Clinical Studies for Supplemental Marketing Approvals

Nobuyuki Sekine, Yasuo Ohashi, Atsushi Aruga

Therapeutic Innovation & Regulatory Science

Select article: The Plant Alkaloid Galantamine: Approved as a Drug;Sold as a Supplement

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Research article

First published 2001-12

The Plant Alkaloid Galantamine: Approved as a Drug;Sold as a Supplement

Joseph R. Cronin

Integrative and Complementary Therapies

Select article: New Drugs Approved by the FDA;Agents Pending FDA Approval;Supplemental Applications Filed by Manufacturer;Significant Labeling Changes

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Research article

First published 2007-10

New Drugs Approved by the FDA;Agents Pending FDA Approval;Supplemental Applications Filed by Manufacturer;Significant Labeling Changes

Danial E. Baker

Hospital Pharmacy

Select article: New Drugs Approved by the FDA Agents Pending FDA Approval Supplemental Applications Filed by Manufacturer Significant Labeling Changes

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Research article

First published 2008-5

New Drugs Approved by the FDA Agents Pending FDA Approval Supplemental Applications Filed by Manufacturer Significant Labeling Changes

Danial E. Baker

Hospital Pharmacy

Select article: New Drugs Approved by the FDA;Agents Pending FDA Approval;Supplemental Applications Filed by Manufacturer;Significant Labeling Changes

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Research article

First published 2007-7

New Drugs Approved by the FDA;Agents Pending FDA Approval;Supplemental Applications Filed by Manufacturer;Significant Labeling Changes

Danial E. Baker

Hospital Pharmacy

Select article: New Drugs Approved by the FDA Agents Pending FDA Approval Supplemental Applications Filed by Manufacturer Significant Labeling Changes

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Research article

First published 2007-12

New Drugs Approved by the FDA Agents Pending FDA Approval Supplemental Applications Filed by Manufacturer Significant Labeling Changes

Danial E. Baker

Hospital Pharmacy

Select article: New Drugs Approved by the FDA;Agents Pending FDA Approval;Supplemental Applications Filed by Manufacturer;Significant Labeling Changes

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Research article

First published 2008-4

New Drugs Approved by the FDA;Agents Pending FDA Approval;Supplemental Applications Filed by Manufacturer;Significant Labeling Changes

Danial E. Baker

Hospital Pharmacy

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