Time and Extent Applications for Nonprescription Drug Products (OTC) Guidance Introduced

According to FDA, “This guidance is intended to explain what information an applicant should submit to the Food and Drug Administration (FDA) to request that a drug product be included in the over-the-counter (OTC) drug monograph system and to describe the process for submitting that  information. FDA regulations set forth criteria and procedures by which…

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Unapproved Drug Enforcement Policy Revised by FDA

On September 19, 2011, FDA published a Notice to Industry announcing its revised Guidance for Marketed Unapproved Drugs – Compliance Policy Guide, replacing the version previously released in June 2006. This guidance represents a shift in FDA’s approach to enforcement actions related to marketed drugs without approved NDAs, ANDAs or OTC monograph compliance.  To learn…

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Literature Search Services

Literature Search Services

The industry professionals at PDG conduct high quality international literature searches across a variety of medical and scientific databases. Customized and Targeted Literature Search Services In providing Literature search services, PDG employs customized and targeted search methods, summary and analyses, extensive electronic library and multi-lingual translation options. Our methods are highly cost-effective and routinely applied…

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Post-Marketing Surveillance – Pharmaceutical Consultants

Post-Marketing Surveillance

International and U.S. companies rely on the expertise and professional resources of PDG to provide dependable, accurate and compliant drug safety programs, pharmacovigilance services and ongoing assessments of labeling accuracy and completeness. An Experienced Post-Marketing Safety Surveillance Team PDG’s array of epidemiologists, clinicians, statisticians, and regulatory experts deliver evidence-based analyses to address the safety and…

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