A Literature Review of Pharmaceutical Process Validation
- FDA to Make Drug Approval Process More Efficient. // Chemical Market Reporter;2/24/2003, Vol. 263 Issue 8, p9
Reports that the U.S. Food and Drug Administration will make drug approval process more efficient. Existing drug approval process; Requirements for drug approval; Implications for the pharmaceutical industry.
- Active Pharmaceutical Ingredient Watch. // Chemical Market Reporter;9/22/2003, Vol. 264 Issue 9, p12
Reports developments on the approval of drugs from the pharmaceutical firms in the U.S. as of September 2003.
- Predictive Toxicology Tools Creep Toward Legitimacy. Coty, Cindy // Drug Discovery & Development;May2003, Vol. 6 Issue 5, p55
Reports on the number of new chemical entities and new drug applications approved by the U.S. Food and Drug Administration (FDA) in 2002. Advice and assistance offered by the FDA to help pharmaceutical companies to embrace drug discovery technologies; Microarray concerns; Uses of preventive...
- Pipeline. // Medical Marketing & Media;Dec2003, Vol. 38 Issue 12, p10
Reports developments related to the pharmaceutical industry in the U.S. Approval of the Lexiva drug of GlaxoSmithKline; Collaboration between Pfizer and Organon; Terms of agreement.
- Pipeline. // Medical Marketing & Media;Jun2010, Vol. 45 Issue 6, p11
The article offers news briefs related to the pharmaceutical industry in the U.S. Including the acquisition of Lysteda drug by Ferring, the approval of Bayer HealthCare's Natazia as an oral contraceptive and the label change approval for Vyvanse capsules CII.
- Push for New Antibiotics Focus. // Chain Drug Review;7/8/2013, Vol. 35 Issue 11, p54
The article informs that federal health officials, pharmaceutical firms and medical experts of the U.S. are focused on quick approval of new medicines in the wake of antibiotic resistant microrganism "superbugs."
- New drugs should be compared with existing treatments before approval, say experts. // Biomedical Market Newsletter;9/12/2011, Vol. 21, p161
The article reports on the argument of pharmaceutical experts which call for the manufacturers to indicate the comparison of their drugs to the existing treatments before approval to ensure the delivery of most effective and safest therapies to patients.
- OTHER NEWS TO NOTE. // BioWorld Today;1/25/2010, Vol. 21 Issue 15, p4
This section offers news briefs related to the pharmaceutical industry, including an investigational new drug application filed by ACT Biotech Inc. for its ACTB1003 oral kinase inhibitor, another on the emergence of Vermillion Inc. from Chapter 11 bankruptcy protection and one on the European...
- pSivida gets NICE approval for Iluvien. // Medical Device Daily;6/18/2013, Vol. 17 Issue 117, p8
The article reports that the company pSivida received approval from the British National Institute for Health and Care Excellence (NICE) to use its drug Iluvien as treatment for pseudophakic patients with chronic diabetic macular edema (DME).