Standards/Regulations

Jun 01, 2003
Pharmaceutical Technology Europe
The US Food and Drug Administration is working with manufacturers to establish new policies for incorporating genomic information into the regulatory process and simultaneously encourage pharmacogenomic research.
May 02, 2003
Pharmaceutical Technology
FDA resolves the bar code labeling debate, releases its GMP requirements for dietary supplements, and proposes a comprehensive adverse-event reporting system.
May 02, 2003
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Pharmaceutical science & technology news.
May 01, 2003
Pharmaceutical Technology Europe
On 20 February 2003, the US Food and Drug Administration (FDA) published a new draft guidance relating to 21 CFR Part 11. The new guidance mainly affects the compliance requirements of systems with a low risk and low impact on product quality; however, systems with a high risk and high impact on product quality, such as chromatography data systems or laboratory information management systems (LIMS), remain unaffected, as this article describes.
May 01, 2003
Pharmaceutical Technology Europe
Regular update from Washington.
May 01, 2003
Pharmaceutical Technology Europe
For nearly 40 years, drug dossiers have supported the quality, safety and risk/benefits of medicinal products. However, electronic technological advances mean that the dossier will soon be a thing of the past - being replaced by e-documents that can be reviewed and approved online by regulators, under the scrutiny of patient groups and with the final blessing of purchasers, as this article examines.
May 01, 2003
Pharmaceutical Technology Europe
By Albedo
Europe's pharmaceutical R&D has recently come under a barrage of criticism. Nobel laureate, Kary Mullis, highlighted the issue of over-legislating biotechnology and the business industry expressed its dismay concerning the EU's overly cautious approach to any kind of development. Action is needed before the sector's future resembles the plot of a Shakespearean tragedy.
May 01, 2003
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors describe the solicitation of industry input for the guidance through a process that included a 2002 meeting of the Advisory Committe on Pharmaceutical Science and the subsequent formation of the PQRI Aseptic Processing Working Group.
Apr 02, 2003
Pharmaceutical Technology
FDA's newly launched risk-based approach to GMP regulation spurs signficant changes in the agency's approach to inspection processes, postapproval changes, and 21 CFR Part 11 enforcement.
Apr 02, 2003
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Pharmaceutical science & technology news.
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