Chris Ignace referenced these FDA documents in his June 10, 2024 RTR presentation:

FDA Guidance: “ANDA Submissions – Refuse-to-receive standards – Guidance for Industry – December 2016 Rev. 2.”

FDA Guidance: “ANDA Submissions – Refuse-to-receive Standards: Questions and Answers – Guidance for Industry – Draft Guidance October 2017”

Meeting Transcripts (PET) - POSITRON EMISSION TOMOGRAPHY (PET) DRUGS: SUBMITTING AN APPLICATION FOR PET DRUGS CURRENTLY IN CLINICAL USE, PUBLIC MEETING, Wednesday, March 2, 2011, 8:30 a.m. to 5:15 p.m.

Sample Formats – Chemistry, manufacturing and Controls Sections, Ammonia N 13 Injection, Fludeoxyglucose F 18 Injection (FDG F 18) and Sodium Fluoride F 18 Injection, 1/25/2011

Guidance PET Drug Applications — Content and Format for NDAs and ANDAs, Fludeoxyglucose F 18 Injection,  Ammonia N 13 Injection , Sodium Fluoride F 18 Injection, Procedural, 8/2011

Policy/Procedure - MAPP 5220.8, OGD, Evaluating Requests, for and Conducting Product Development and Pre-Submission Pre-ANDA Meetings, 10/5/2022

Policy/Procedure - MAPP 5220.5 Rev. 2 OGD, Issuance of Information Requests and/or Discipline Review Letters for Abbreviated New Drug Applications, 10/5/2022

Guidance - Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe, Guidance for Industry, Generics, 12/2022

Guidance - Determining Whether to Submit an ANDA or a 505(b)(2) Application, Guidance for Industry, Generics, 5/2019 (Draft)

Guidance - Referencing Approved Drug Products in ANDA Submissions, Guidance for Industry, Generics, 10/2020

MAPP 5240.3 Rev. 6, OGD,  Prioritization of the Review of Original ANDAs, Amendments, and Supplements (current 2020)

Guidance - Competitive Generic Therapies, 10/2022, Generic Drugs

ANDA “checklist” that Ravi Kasliwal (FDA) referred to during the Q&A time
The checklist begins on page 9.