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

NDA and ANDA approvals

PDG and its staff have participated in more than 100 505(j) abbreviated new drug applications (ANDA) submissions.

PDG is well-versed in the requirements for safety and bioequivalence studies (and when applicable, bio-waivers); labelling; chemistry, manufacturing, and controls (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 the US Food and Drug Administration (FDA).

Support for diversification and generic drug development

Whether you are a foreign firm contemplating your first US generic development project, or an established US generic firm seeking to undertake a 505(b)(2) development programme, PDG supports generic manufacturers in the diversification of their development programmes to include commercially reasonable 505(j), 505(b)(1) and 505(b)(2) NDA opportunities.

PDG also has extensive experience with pharmaceutical labelling of new drug applications (NDA), ANDAs, and supplements. The 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 labelling.

If implemented, generic companies will have a paradigmatic shift in their role related to safety surveillance and labelling 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 labelling.

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