Generic Drug Development: 505(j) ANDAs and Potential Diversification

ANDA Submissions

PDG and staff have participated in over one hundred 505(j) Abbreviated New Drug Applications (ANDA) submissions.

PDG is well-versed in the requirements for safety and bioequivalence studies (and when applicable, bio-waivers), labeling, CMC and the potential of patent challenges. PDG will orchestrate ANDA drug candidate selections, compilation and submission of the application including patent and RLD considerations, maintenance activities and interactions with FDA.

Support for Diversification and Generic Drug Development

Whether you are a foreign firm contemplating your first U.S. generic development project, or an established U.S. generic firm seeking to undertake a 505(b)(2) development program, PDG supports generic manufacturers in the diversification of their development programs to include commercially reasonable 505(j), 505(b)(1) and 505(b)(2) NDA opportunities. Click here to learn more about our NDA development efforts.

PDG also has extensive experience with pharmaceutical labeling of NDAs, ANDAs, and Supplements. FDA recently announced critically important information for all generic drug manufacturers which may require generic drug manufacturers to develop and implement safety-related changes to their labeling. If implemented, generic companies will have a paradigmatic shift in their role related to safety surveillance and labeling updates. PDG is uniquely positioned to assist with any new FDA post-marketing requirements, safety assessments and pharmacovigilance efforts to help ensure the continued adequacy of professional labeling.

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