Anne Pariser

Anne Pariser

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Anne Pariser

Anne Pariser

Publications by authors named "Anne Pariser"

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Investigational New Drug applications: a 1-year pilot study on rates and reasons for clinical hold.

J Investig Med 2016 Feb;64(2):376-82

Office of Translational Sciences, CDER, FDA, Silver Spring, Maryland, USA.

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http://dx.doi.org/10.1136/jim-2015-000010DOI Listing
February 2016

Pre-Investigational New Drug Meetings With the FDA: Evaluation of Meeting Content and Characteristics of Applications for New Drug and Biologic Products.

Ther Innov Regul Sci 2015 May;49(3):434-442

1 Office of New Drugs, Rare Diseases Program, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.

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http://dx.doi.org/10.1177/2168479014558275DOI Listing
May 2015

Important role of translational science in rare disease innovation, discovery, and drug development.

J Gen Intern Med 2014 Aug;29 Suppl 3:S804-7

Office of New Drugs, Rare Diseases Program, Center for Drug Evaluation and Research, Food and Drug Administration, WO22-6471, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA,

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http://dx.doi.org/10.1007/s11606-014-2881-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4124126PMC
August 2014

Phenylketonuria Scientific Review Conference: state of the science and future research needs.

Mol Genet Metab 2014 Jun 6;112(2):87-122. Epub 2014 Mar 6.

The Young Face, Facial Plastic and Reconstructive Surgery, Cumming, GA 30041, USA. Electronic address:

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https://www.team-share.net/Phenylketonuria_Scientific_Review
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http://linkinghub.elsevier.com/retrieve/pii/S109671921400085
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http://dx.doi.org/10.1016/j.ymgme.2014.02.013DOI Listing
June 2014

Rare cancer trial design: lessons from FDA approvals.

Clin Cancer Res 2012 Oct 20;18(19):5172-8. Epub 2012 Jun 20.

Food and Drug Administration, National Cancer Institute Interagency Oncology Task Force, MD, USA.

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http://dx.doi.org/10.1158/1078-0432.CCR-12-1135DOI Listing
October 2012

Cross-sector sponsorship of research in eosinophilic esophagitis: a collaborative model for rational drug development in rare diseases.

J Allergy Clin Immunol 2012 Sep 31;130(3):613-6. Epub 2012 Jul 31.

Division of Gastroenterology and Inborn Errors Products, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

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http://dx.doi.org/10.1016/j.jaci.2012.07.011DOI Listing
September 2012

Characteristics of rare disease marketing applications associated with FDA product approvals 2006-2010.

Drug Discov Today 2012 Aug 5;17(15-16):898-904. Epub 2012 May 5.

Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.

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http://dx.doi.org/10.1016/j.drudis.2012.04.011DOI Listing
August 2012

The role of immune tolerance induction in restoration of the efficacy of ERT in Pompe disease.

Am J Med Genet C Semin Med Genet 2012 Feb 17;160C(1):30-9. Epub 2012 Jan 17.

Office of Pharmaceutical Science, Office of Biotechnology Products, Division of Therapeutic Proteins, Center for Drug Evaluation and Research, Food and Drug Administration, Bethesda, MD 20892, USA.

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http://dx.doi.org/10.1002/ajmg.c.31316DOI Listing
February 2012

Clinical pharmacology as a cornerstone of orphan drug development.

Nat Rev Drug Discov 2011 10 31;10(11):795-6. Epub 2011 Oct 31.

Office of Translational Sciences, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, USA.

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http://dx.doi.org/10.1038/nrd3595DOI Listing
October 2011

Regulatory considerations for developing drugs for rare diseases: orphan designations and early phase clinical trials.

Discov Med 2011 Apr;11(59):367-75

Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, USA.

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April 2011

Accelerating orphan drug development.

Nat Rev Drug Discov 2010 Dec;9(12):901-2

Office of the Commissioner, Office of Orphan Products Development, Silver Spring, Maryland 20993, USA.

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http://dx.doi.org/10.1038/nrd3340DOI Listing
December 2010

Training the translational scientist.

Sci Transl Med 2010 Dec;2(63):63mr2

Center for Clinical and Translational Science, Ohio State University, Columbus, OH 43210, USA.

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http://dx.doi.org/10.1126/scitranslmed.3001632DOI Listing
December 2010

Therapies for inborn errors of metabolism: what has the orphan drug act delivered?

Pediatrics 2010 Jul 21;126(1):101-6. Epub 2010 Jun 21.

Food and Drug Administration, Office of Orphan Products Development, Silver Spring, MD 20993-0002, USA.

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http://dx.doi.org/10.1542/peds.2009-3246DOI Listing
July 2010

Neutralizing antibodies to therapeutic enzymes: considerations for testing, prevention and treatment.

Nat Biotechnol 2008 Aug;26(8):901-8

Division of Therapeutic Proteins, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, NIH Building 29B, 8800 Rockville Pike, Bethesda, Maryland 20892, USA.

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http://dx.doi.org/10.1038/nbt.1484DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3478093PMC
August 2008