Regulatory Affairs Updates: Latest on ANDA User Fees (GDUFA)

FDA and industry leaders have agreed on legislation that, if passed by Congress, will usher in user fees for ANDA sponsors. As currently drafted, a one-time backlog fee is anticipated for “Each person that owns an abbreviated new drug application (ANDA) that is pending on October 1, 2012, and that has not received a tentative…

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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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