Legal Support
PDG provides litigation support and research, as well as expert testimony, to the legal community for qualifying cases.
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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Pre NDA Meeting and NDA Submission: 505(b)(1)/505(b)(2)
PDG has participated in multiple NDAs (505(b)(1) and 505(b)(2)) and sNDAs, including first-in-class drug products, new chemical entities, Rx-to-OTC switches, and fixed-dose combinations.
505(b)(2) NDAs
Many PDG clients have found the 505(b)(2) NDA development pathway to be a more timely and cost-effective route to market.
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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Combination Products and Combination Drug Therapies
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.
Generic Drug Development: 505(j) ANDAs and Potential Diversification
PDG and staff have participated in over one hundred 505(j) Abbreviated New Drug Applications (ANDA) submissions.
Literature Search Services
The industry professionals at PDG conduct high quality international Literature search services 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…
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Nonprescription OTC Drug Development
As regulatory strategists, our view of non prescription drug Product 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…
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