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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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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PDG has extensive experience in the development of drug/device combination products and combination drug therapies, including all IND and NDA requirements for both fixed-dose combinations or co-packaged drugs.
PDG and staff have participated in over one hundred 505(j) Abbreviated New Drug Applications (ANDA) submissions.
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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As regulatory strategists, our view of nonprescription drug development (aka Over-the-Counter or OTC) certainly includes new OTC launches and Rx-to-OTC switches. However, there are many lesser known nonprescription OTC drug development opportunities that PDG can help with. Click through these four Q&As to learn more. As you do so, keep in mind that the experienced…
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Post-launch activities for a new drug require companies to rigorously track, report, and evaluate worldwide adverse event information. Such drug post-launch activities are critically important to ensure current benefit/risk profiles and the dissemination of labeling that fully describes the safe use of a drug product.
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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Our team of full time professional staff and expert consultants are well-versed in the nuances of professional and promotional labeling including website review.
Imagine the value of continuous access to the specialty pharmaceutical consulting services and resources necessary to complete tasks that are out of the ordinary, unexpected, or for which you just don’t have time.