Approval process of FDA provides consumers benefit from having access to safe and effective medical products and foods. FDA approves
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Are You 505(b)(2) Savvy? Find out if you understand the intricacies of these IND/NDAs!
Investigational New Drugs/New Drug Applications (INDs/NDAs) filed as 505(b)(2) products represent a “hybrid,” faster process for FDA approval of new
...Continue readingFDA’s Quality Metrics Guidance for the Pharmaceutical Industry
In July of 2015 the FDA issued a draft of guidance, “Request for Quality Metrics” in order to monitor quality
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Calibration in FDA Regulated Laboratories
Healthcare is heavily dependent upon various different kinds of technology, which often come from different eras – while a substantial
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FDA’s Regulatory Measures on Opioid Pain Management
The use of chronic opioid therapy for chronic non malignant pain has increased significantly and is associated with significant morbidity
...Continue readingAttaining FDA Export Certificates For Regulated Products: Practical Insights
The products that are exported from the United States are issued a certificate from the Food and Drug Association (FDA).
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Exporters of FDA Regulated Products – Get your Export Certificates in Order!
Exporters had a great last year and 2015 is all set to be even better. With President Obama announcing the
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Forging Ahead With Tightening Standards in Pharmacovigilance
Pharmacovigilance is the science related to collecting, detecting, monitoring and analyzing the adverse effects of pharmaceutical products. Pharmacovigilance primarily talks
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