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- The quality of quality control.(member forum)(Food and Drug Administration to increase the security of medication supply chain )
- THE U.S. FOOD AND DRUG ADMINISTRAtion is trying to increase the security of the medication supply chain by decreasing medication error, counterfeit drugs, and the threat of terrorist sabotage. To combat medication errors in hospitals, the FDA now req THE U.S. FOOD AND DRUG ADMINISTRAtion is...
- Research articles 2007-11-01
- Document management software.(Manufacturing Focus: Quality Control and Inspection)(Brief Article)
- QualTrax has launched a document management software package to help companies comply with FDA Section 21 CFR Part 11. QualTrax Rx features electronic signature authentication, PDF rendering for tamperproof documents, different levels of document s QualTrax has launched a document management software package to...
- Research articles 2005-04-01
- Project: FANS: FDA's Crackdown on Wyeth Reveals Drug Conglomerate's Hypocrisy
- WASHINGTON, June 5 /U.S. Newswire/ -- Project: FANS-a grassroots effort to protect Americans' access to safe, natural medical solutions-expressed its discontent today over recent news that Wyeth Pharmaceuticals was pushing a so-called citizen's complaint WASHINGTON, June 5 /U.S. Newswire/ -- Project: FANS-a grassroots effort to protect Americans' access to safe,...
- Research articles 2006-06-05
- This Assay is the First to Gain FDA Approval for Drug Quality Control
- The U.S. Food and Drag Administration (FDA; Rock ville, MD; www.fda.gov) granted GlaxoSmithKline (GSK; Research Triangle Park, NC; www.gsk.com) approval to use Pall Corp.'s (East Hills, NY; www.pall.com) Pallchek Luminometer, a rapid microbiological detection RMD instrument, to monitor the quality of a prescription nasal spray product used to treat migraines,...
- Research articles 2004-07-01
- It's Not Mylan's First Quality Control Beef With FDA
- If you're following Mylan's fight with the FDA over whether the agency did or did not give the generic maker a clean bill of health at its Morgantown, W. Va., factory, you'll be interested to know that this is not the first time the FDA has frowned upon the company....
- Blog posts 2009-07-28
Additional Resources
- Caraco Pharma Awaits FDA Inspection in May
- Mike Havrilla submits: I spoke with the investor relations representative for Caraco Pharma CPD earlier this week and received some clarity on the expected timeline for resolving the major overhang on the stock price related to the FDA warning letter over Form 483 concerns by the agency stemming from quality...
- External links 2009-02-25
- Gene Express Participates in FDA's Micro Array Quality Control Consortium
- Gene Express, Inc. today announced its participation in the Micro Array Quality Control MAQC Consortium, assembled by the U.S. Food and Drug Administration FDA to evaluate micro array and alternative gene expression platforms and to establish quality control parameters.
- Research articles 2006-03-01
- Stratagene Highlights Results of FDA's MicroArray Quality Control Project; Stratagene's Universal Reference RNA Proves Valuable as a Reference Standard for Comparing Results From Many Microarray Platforms
- LA JOLLA, Calif. -- Stratagene Corporation (NASDAQ:STGN), a developer, manufacturer and marketer of specialized life science research and diagnostic products, today highlighted the U.S. Food and Drug Administration's FDA publication of results from its MicroArray Quality Control MAQC project.
- Research articles 2006-09-12
- Clinical Data, Inc. Plays Integral Role in MicroArray Quality Control Consortium Project; FDA-Led Initiative Assessing Reproducibility of Microarray Data Featured in September 2006 Edition of Nature Biotechnology
- NEWTON, Mass. -- Cogenics, a division of Clinical Data Inc. (NASDAQ: CLDA) and comprised of the combined companies of Genaissance Pharmaceuticals, Lark US and UK, Icoria, and Genome Express of France, today joined with other participants of the MicroArray Quality Control MAQC Consortium in publishing the results of the FDA-led...
- Research articles 2006-09-08
- New Software for Agilent Bioanalyzer Features Unique RNA Quality Control, FDA Compliance Tools
- PALO ALTO, Calif. -- Agilent Technologies Inc. (NYSE:A) today introduced new software for the Agilent 2100 bioanalyzer that includes a unique RNA Integrity Number algorithm for RNA quality control and tools for compliance with FDA rule 21 CFR Part 11, which governs data security, access and electronic signatures. The Agilent...
- Research articles 2005-07-14
- Expression Analysis Announces its Participation in the First Phase of the MicroArray Quality Control Project Sponsored by the FDA
- DURHAM, N.C. -- Expression Analysis, Inc., a full-service microarray testing, analysis and data management organization, has announced its participation as an official data analysis site in the first phase of the Federal Drug Administration's MicroArray Quality Control MAQC Project. The completion of this phase of the project is described in...
- Research articles 2006-09-11
- Affymetrix Participates in Study to Advance MicroArray Technology Towards Widespread Clinical Use; GeneChip® Technology Demonstrates Top Performance in MicroArray Quality Control Study
- SANTA CLARA, Calif. -- Affymetrix Inc. (Nasdaq:AFFX) announced today the publication of the MicroArray Quality Control MAQC study, a collaborative effort led by the FDA that included 137 scientists from private and public sector laboratories. Affymetrix and other microarray and reagent manufacturers participated in the two-year initiative designed to address...
- Research articles 2006-09-08
- Asuragen Joins Industry Leaders in Completion of the FDA MAQC Project
- AUSTIN, Texas -- Asuragen, Inc., an oncology molecular diagnostic company and molecular biology service provider, announces its participation as an Affymetrix test site for the U.S. Food and Drug Administration's Micro Array Quality Control MAQC Consortium, the results of which were published in this month's issue of Nature Biotechnology. The...
- Research articles 2006-09-11
- Comprehensive Product Quality System to Achieve FDA Compliance
- A leading international medical device and pharmaceutical company needed to redefine and redeploy their entire quality system in response to the results of an FDA inspection. PRTM led the overall quality system redesign and implementation effort. It created seven internal teams to address each of seven components of the quality...
- Case studies
- Change Control in the FDA-Regulated Industry
- Change control is the most critical element in a pharmaceutical or biotech company's quality management system - inadequate change control procedures end up creating a huge risk of non-compliance. The FDA's guidance for Industry clearly reinforces the importance of implementing an effective change control procedures as a critical component in...
- White papers
- Watchdog Group Asks FDA To Check Out Schering-Plough.(Government Activity)(Brief Article)
- A CONSUMER WATCHDOG group is asking Food and Drug Administration FDA to investigate quality control problems at a Schering-Plough Corporation pharmaceutical plant, and to consider whether criminal charges are warranted. In a letter sent to A CONSUMER...
- Research articles 2001-03-12
- FDA Sends Warning Letter to Genentech After Inspection.(Brief Article)
- THE FOOD AND Drug Administration has ordered biotech firm Genentech Inc. to improve quality control at its South San Francisco, Calif., plant after inspectors found contaminated batches of drugs. In a warning letter, FDA said Genentech could f THE...
- Research articles 2001-01-08
- Extreme FDA Trades on Pending Smallcap Medical Device Decisions
- Mike Havrilla submits: Below is a sample of extreme FDA trades on pending medical device decisions (510k or PMA filings) among companies with market caps below $150 million (M) which are taken from the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA...
- External links 2009-05-26
- FDA, Clinical Trial Calendar Updates: Discovery, Impax Labs
- Mike Havrilla submits: Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision...
- External links 2009-04-21
- New FDA initiative invites advanced controls: Process Analytical Technologies guidelines, issued in September 2004, are encouraging use of new technologies for design, analysis, and manufacturing control in pharmaceutical industry.(INSIDE PHARMA)
- Officials from the U.S. FDA publicly asked technology experts in other industries to find performance-enhancing technologies that could help pharmaceutical manufacturers cut costs, improve product quality or speed to market, during the November 200 Officials from the U.S. FDA publicly asked technology experts in...
- Research articles 2005-04-01
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