Combination Products and Combination Drug Therapies

505(b)(2) NDAs

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. This includes interactions with the Office of Combination Products, meetings with multiple divisions within the Center for Drug Evaluation and Research (CDER) and/or the Center for Devices and Radiological Health (CDRH).

PDG has prepared meeting requests and briefing packages, met with FDA, proposed investigational plans to FDA, reviewed non-clinical and clinical data generated with related device and drug products and is engaged in ongoing development efforts involving novel combination products. PDG understands the unique variants of combination product submissions. PDG is experienced across the spectrum of all IND and NDA requirements including:

  • Strategy development
  • CMC
  • Toxicology
  • Pharmacokinetics
  • Clinical efficacy
  • Clinical safety
  • Labeling
  • FDA grants of exclusivity
  • Patent submissions & grants
  • NDA line extensions
  • Published clinical literature
  • Nonprescription products
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