Toxicological Insights for the Global Pharmaceutical Industry
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Dried Blood Spot Analysis: Preclinical Pros and Cons
Both advantages and challenges exist for use of dried blood spots during preclinical drug development, and global regulatory acceptance is uncertain.
Personalized Medicine: Friend or Foe?
Personalized medicine is anticipated to enhance drug safety of both new and existing medications, but it may also increase preclinical development costs, limit the potential market, and lower pharmaceutical sales.
FDA Sentinel Initiative: Public / Private Postmarketing Surveillance
Through initiation of the Sentinel Initiative (May 2008), the Food and Drug Administration (FDA) is developing the capacity for actively monitoring the safety of approved medical products using the electronic health information in claims systems, inpatient and outpatient medical records, and patient registries.
Advantages of Incremental Innovation in Drug Development
Most new drugs represent a combination of small improvements achieved over time and ultimately reflect advances in safety, efficacy, selectivity, and drug utility.
Drug Labels May Inadequately Address Efficacy and Risk
Drug labels may insufficiently address efficacy and risks/toxicity. Label changes, among others, have been proposed and are under review by the FDA.
New Center of Excellence for Regulatory Science proposed by FDA
New center of excellence in regulatory science proposed by the FDA will bring academia, FDA, and industry together in collaboration.
Australian TGA adopts ICH M3(R2) Nonclinical Guidance
The Australian TGA has adopted the EU ICH M3(R2) guidance for nonclinical (toxicology) safety studies of pharmaceuticals.
New FDA Transparency Impacts Drug Safety
Analyses of publically available clinical data may present the FDA with a more complex picture of drug safety, but may complicate regulatory assessment.
How to ensure the long-term safety of chronic use drugs?
Drug safety may be underestimated for chronic-use drugs.
Why is naming a drug so difficult?
The FDA published a guidance (February 2010) detailing the methodology for evaluating proposed proprietary drug names.
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