RTR a New Q&A Guidance!

OGD has released a new Q&A document relative to refuse-to-receive issues.  I must be quite frank, there were some questions and their answers of which I was not aware.  Everyone submitting an ANDA should thoroughly review this draft guidance and assure that your ANDA conforms to all of the conditions specified in the document prior to filing.

The questions and answers document covers the following categories:

  • Scope (what filings are subject to RTR standards)
  • Responding to deficiencies and RTR determinations
  • General deficiencies
  • Drug Master File review and deficiencies
  • Product quality deficiencies
  • Bioequivalence and clinical deficiencies

As a for instance, I was not fully aware of the scope of documents covered by the RTR provisions.  FDA states the following:

Q1: To which generic drug product submissions do this guidance and the RTR Standards guidance apply?

A1: This guidance and the RTR Standards guidance apply to original abbreviated new drug applications (ANDAs) and certain prior approval supplements (PASs) to ANDAs consistent with our current practices, including those in which the applicant is seeking approval of a new strength, reformulation of a drug product that does not require a new original ANDA submission, return of a discontinued product to the market, and Rx-to-OTC switches for all conditions of use.

Now come on, did you know that the RTR provisions applied to the return of a discontinued product to the market?  Really???

The are some other golden nuggets buried in this document but I am going to let you find them (here) After all, I am on vacation!