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Articles (36)

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1-10 of 36 results for Orphan drug applicants

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Select article: Applications of the Orphan Drug Act to Special Patient Populations

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Research article

First published 1994-4

Applications of the Orphan Drug Act to Special Patient Populations

Marlene E. Haffner

Therapeutic Innovation & Regulatory Science

Select article: Development of Orphan Drugs in Japan: Characteristics of Orphan Drugs Developed in Japan *

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Other

First published 2000-7

Development of Orphan Drugs in Japan: Characteristics of Orphan Drugs Developed in Japan *

Makoto Shiragami, Kiyohito Nakai

Therapeutic Innovation & Regulatory Science

Select article: Gaucher Drug Rejected in Europe;Should Orphan Drug Status for Another Company's Drug Apply on Grounds of Cost?

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Research article

First published 2013-04

Gaucher Drug Rejected in Europe;Should Orphan Drug Status for Another Company's Drug Apply on Grounds of Cost?

Biotechnology Law Report

Select article: Quantum of Effectiveness Evidence in FDA’s Approval of Orphan Drugs

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Research article

First published 2015-9

Quantum of Effectiveness Evidence in FDA’s Approval of Orphan Drugs

Frank J. Sasinowski, Erika B. Panico, James E. Valentine

Therapeutic Innovation & Regulatory Science

Select article: Orphan Drugs in Japan

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Research article

First published 1996-1

Orphan Drugs in Japan

Kosaku Uchida

Therapeutic Innovation & Regulatory Science

Select article: Critical Drug Information Not Reaching Prescribers;Guidance for REMS;Stem Cell Trial for ALS Scheduled;Orphan Drug Status for a Gene Therapy;Safe Use Initiative from FDA;Antigenics Withdraws European Oncophage Application

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Other

First published 2009-12

Critical Drug Information Not Reaching Prescribers;Guidance for REMS;Stem Cell Trial for ALS Scheduled;Orphan Drug Status for a Gene Therapy;Safe Use Initiative from FDA;Antigenics Withdraws European Oncophage Application

Biotechnology Law Report

Select article: Successfully Navigating Food and Drug Administration Orphan Drug and Rare Pediatric Disease Designations for AAV9-hPCCA Gene Therapy: The National Institutes of Health Platform Vector Gene Therapy Experience

Open access

Research article

First published 2023-03

Successfully Navigating Food and Drug Administration Orphan Drug and Rare Pediatric Disease Designations for AAV9-hPCCA Gene Therapy: The National Institutes of Health Platform Vector Gene Therapy Experience

Richa Madan Lomash, Oleg Shchelochkov, Randy J. Chandler [...]

Human Gene Therapy

Select article: Functional Genomics and the Discovery of New Drug Targets

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Research article

First published 1999-03

Functional Genomics and the Discovery of New Drug Targets

Olivier Civelli, Hans-Peter Nothacker

Diabetes Technology & Therapeutics

Select article: Human growth hormone: challenge to non-therapeutic and experimental use

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Research article

First published 1993-3

Human growth hormone: challenge to non-therapeutic and experimental use

Joseph Mendelson

International Journal of Risk & Safety in Medicine

Select article: Orphan Drug Programs/Policies in Australia,Japan,and Canada

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Other

First published 2001-1

Orphan Drug Programs/Policies in Australia,Japan,and Canada

Drusilla L. Scott, Susan Alder, Etsuko Usui [...]

Therapeutic Innovation & Regulatory Science

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