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New FDA Postmarketing Drug Safety Evaluation Website
As of 15 June 2010, the new Food and Drug Administration (FDA) Postmarketing Drug Safety Evaluation website was launched. The FDA posted postmarket safety evaluations for 26 drugs approved between September 2007 and January 2008 and is reviewing an additional 20 or 30 others. To date, no label changes have been recommended.
New FDA Safety Reporting Portal
On May 24, 2010, the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) launched a new Web site that, when fully developed, will provide a mechanism for the reporting of pre- and post-market safety data to the federal government.
Postmarket Drug Safety: Institute of Medicine Recommendations to FDA
The Institute of Medicine (IOM) gives recommendations to the FDA on when and how to conduct clinical trials ethically to evaluate postmarket drug safety.
New Comprehensive Website for European Medicines Agency
On 15 July 2010 the European Medicines Agency (EMA) launched a new comprehensive website.
FDA New On-Line Quarterly Drug Safety Summary and REMS are Complimentary Efforts
As of 15 June 2010, potential signals of serious risks/new drug safety information identified from the Adverse Event Reporting System (AERS) will be published by the FDA in quarterly on-line reports. These safety summaries, which will appear within roughly 2 years post-approval, will address safety risks that were not identified during a drug’s development or prior to FDA approval.
Global Approval of Renal Toxicity Biomarker Panel for Preclinical Studies
The new 7 renal biomarker panel is qualified for use globally in nonclinical safety studies, and will be accepted on a case-by-case basis for use in monitoring drug-induced renal toxicity in humans.
FDA – Standards, Publications, Regulations and Laws, Recalls, and Safety News (Four CD-ROM Set)
Now available, a comprehensive superset of 4 CD‑ROMs which provide an up-to-date collection of documents, manuals, publications, and reference sources on the FDA, including drug safety.
Can the FDA Go Public with Proprietary Information?
The FDA proposes publishing drug/device rejection letters, including any safety concerns that led to the decision.
Orphan Drug Development: Midsize to Large Company Perspectives
Blockbusters can get their start in rare diseases. Orphan indication exclusivity can be one aspect of a profitable drug’s overall product life cycle, including non-orphan uses, and can contribute to its profitability.
FDA Encourages Applications for Orphan-Drug Status
The FDA is offering intensive workshops to give on-the-spot regulatory advice to companies ready to file orphan drug applications by the end of the 2-day period. European meetings may be forthcoming.
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