Search CORE

4 research outputs found

The Single Controlled Trial: Industry Survey Indicates that Implementation is Still a Work in Progress

Author: Clinical development times for new drugs drop 18% reversing 12-yr trend.
DM Cocchetto
European Medicines Evaluation Agency.
FDA Backgrounder
FoodDrug Administration Modernization Act of 1997.
House Report 105–310 to accompany H.R. 1411.
J Kulynych
KD Weiss
M Mathieu
New paradigms for clinical development of biologic products.
P Botstein
PDUFA III could move through Congress in 2001 Rep.
R Temple
US FoodDrug Administration.
US FoodDrug Administration.
Publication venue: 'SAGE Publications'
Publication date
Field of study

A Primer on CBER’s Regulatory Review Structure and Process

Author: Center for Biologies EvaluationResearch CBER
Complete ReviewIssuance of Action Letters.
Designation of License Application Amendments as Major or Minor.
Guidance for Industry.
Guideline for Drug Master Files.
Intercenter Agreement Between the Center for Biologics EvaluationResearchthe Center for DevicesRadiological Health.
Intercenter Agreement Between the Center for Drug EvaluationResearchthe Center for Biologies EvaluationResearch.
KC Zoon
KC Zoon
Procedure for the Classification of Resubmissions of an Application for a Product Covered by the Prescription Drug User Fee Act PDUFA.
Suzanne M. Sensabaugh
Publication venue: 'SAGE Publications'
Publication date
Field of study

Evaluating Benefit-risk Decision-making in Spinal Muscular Atrophy: A First-ever Study to Assess Risk Tolerance in the SMA Patient Community

Author: Armstrong
Arnold
Bach
Belter
Belter
Bertini
Cano
Cheung
Cure
Darras
Dubowitz
Erdem
FDA Guidance (PDUFA)
Finkel
Finkel
Finkel
Finkel
Flynn
Franson
Gallego
Glascock
Hollin
Hunter
Iannaccone
Johnson
Keefe
Kolb
Lally
Lefebvre
Louviere
McGraw
Mercuri
Mercuri
Morel
Munsat
Ogino
Oskoui
Parrish
Pearn
Peay
Peay
Peay
Pera
Prior
Qian
Ross
Rouault
Russman
SMA Europe and TREAT-NMD
Sugarman
US Food & Drug Administration Center for Devices and Radiologic Health Workshop
Verhaart
Wadman
Wang
Warner-Czyz
Wee
Wirth
Wirth
Wittenberg
Zerres
Publication venue: 'Elsevier BV'
Publication date
Field of study

FDA drug approval intervals from 1997 to 2006: analysis and comparison during information technology implementation

Author: Adams
Becker
Berndt
Bernstein
Borchardt
Carpenter
Center
Christopher M. Keller
Conover
DiMasi
DiMasi
Dranove
FDA Announces Standard Format that Drug Sponsors can use to Submit Drug Clinical Trial Data (2004)
FDA Awards up to $2.5 Billion to Modernize Information Technology over Ten Years - Cornerstone of 21st Century Bioinformatics Initiative (2008)
FDA drug approval time speeds up slightly (2002) 25 January. Available online at: http://ap.org/FDA_drug_approval_time_speeds_up_slightly_htm
FDA panel cites Shortfalls in Technology
FDA points to decline in drug review times in 1995 (1996)
FDA proposes first requirement for electronic submissions (2002) Available online at: www.fda.gov/fdac/special/newdrug/benefits.html
FDA shortens drug approval times in 1994
Feuerstein
Hartzband
John F. Kros
Kaitin
Kros
Meadows
Norusis
Novack
PDUFA
Pierson
Rawson
Reid
Publication venue: 'Inderscience Publishers'
Publication date: 01/01/2009
Field of study

core

core