| PDA workshop on "Quality by Design for Biopharmaceuticals: Concepts and Implementation", May 21-22, 2007, Bethesda, Maryland. | |
| | |
MedLine Citation:
|
PMID: 19055233 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
Janet Woodcock, MD, Deputy Commissioner for Operations/Chief Medical Officer at FDA, closed the workshop. She stated that, "QbD represents an evolution and not a revolution" that is in response to the increasing cost pressures on both the regulatory agencies and industry to control the escalation of drug prices. She acknowledged that the successful implementation will require efforts and cooperation between industry and the FDA. She also said that the realization of the full benefits of implementing QbD will require changes in the way industry operates and in the regulations, and thus will take time. The issue of the lack of harmonization of these concepts across different regulatory agencies was recognized as a significant deterrent for companies to implement QbD. FDA is working with other major regulatory agencies to seek better alignment. The Agency also acknowledged that the concepts and associated flexibility of QbD has not yet reached the inspectional arena. The establishment of a "Pharmaceutical Inspectorate" that would standardize an approach and hopefully become an international organization was suggested as a potential outcome of the ongoing efforts. |
| | |
Authors:
|
Anurag S Rathore; Rebecca Devine |
Related Documents
:
|
14640293 - Pharmacogenomics as an aspect of molecular autopsy for forensic pathology/toxicology: d... 12452493 - Failure of national guidelines to diagnose uncomplicated malaria in bangladesh. 19962913 - Evaluation of resident familiarity and utilization of the acr musculoskeletal study app... |
Publication Detail:
|
Type: Congresses |
Journal Detail:
|
Title: PDA journal of pharmaceutical science and technology / PDA Volume: 62 ISSN: 1079-7440 ISO Abbreviation: PDA J Pharm Sci Technol Publication Date: 2008 Sep-Oct |
Date Detail:
|
Created Date: 2008-12-05 Completed Date: 2009-01-07 Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 9439538 Medline TA: PDA J Pharm Sci Technol Country: United States |
Other Details:
|
Languages: eng Pagination: 380-90 Citation Subset: IM |
Affiliation:
|
Amgen Inc., Thousand Oaks, CA 91320, USA. asrathore@yahoo.com |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Chemistry, Pharmaceutical Drug Compounding Drug Design* Drug Industry Interdisciplinary Communication Pharmaceutical Preparations / chemistry* Quality Control Reproducibility of Results Technology, Pharmaceutical / methods*, standards Terminology as Topic United States United States Food and Drug Administration |
| Chemical | |
Reg. No./Substance:
|
0/Pharmaceutical Preparations |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Transfersomes: self-optimizing carriers for bioactives.
Next Document: Perineal infiltration anaesthesia for episiotomy: a needle which is bent manually may break off and ...