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505(b)(2) – Part 2: The Assessment: Preclinical Review/Preclinical Plan

Rats, mice, dogs, pigs – ANDA folks don’t have to deal with testing generic products in animals.  As long as the excipients are previously approved, generic drugs don’t have to conduct any preclinical studies. 505(b)(2) development programs may need to include some preclinical studies depending mainly on whether the route of administration changes or FDA standards have changed since the RLD was approved.

The Preclinical Review is designed to provide an in-depth review of all available preclinical information (i.e. published literature [Toxnet; National Toxicology Program; PubMed], Freedom of Information (FOI) requests or [provided in the Summary Basis for Approval (SBA) documents for approved NDA products], approved labeling, etc.) pertaining to the proposed product.  For products selected to follow the 505(b)(2) pathway, this information is used to support a request for waiver(s) of some or all of the preclinical requirements needed for regulatory submission.

The Preclinical Review includes:

  • Studies supporting preclinical efficacy and safety
  • Carcinogenesis, mutagenesis, and impairment of fertility
  • Pregnancy
  • Teratogenic effects
  • Non teratogenic effects

What we’re doing is looking at what information exists compared to the current regulatory requirements.  The difference is what the sponsor will require to furnish in the 505(b)(2) NDA, unless Camargo can develop a rationale why it does not apply.

In this section we also may consider pre-clinical requirements for any proposed excipients that are not already accepted as safe, either because they are new, new route of administration or result in higher than approved exposure.