GDF 2024 | D1S15 - ANDA Project Management Topics: PLAIR and Cover Letter Attachments

Описание: This presentation provided a PLAIR overview and explained product eligibility requirements, along with OGD's PLAIR process for ANDAs. The session described the purpose of cover letters and cover letter attachments in ANDA submissions. Key procedural aspects and documentation requirements for effective PLAIR submissions and proper cover letter preparation were outlined to support successful application management.

Timestamps

00:59 – An Overview to the Pre-Launch Activities Importation Request (PLAIR)

02:21 – When to Submit a PLAIR

03:31 – What Must Be Included in a PLAIR

05:44 – Importation of a PLAIR

07:46 – Resources

09:02 – PLAIR Process

10:29 – PLAIR Goal

16:05 – Summary – Part 2

17:13 – Purpose of a Cover Letter

17:34 – ANDA Submissions: Content and Format - Guidance

19:00 – Cover Letter Components

24:24 – Best Practices

25:49 – Summary – Part 3

Speakers:

Andrew Kim
Commander (CDR), United States Public Health Service (USPHS)
Supervisory Project Manager
Division of Project Management (DPM)
Office of Regulatory Operations (ORO)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER) | FDA

Andrei Perlloni
Branch Chief
Imports Compliance Branch (ICB)
Division of Global Drug Distribution and Policy (DGDDP)
Office of Drug Security, Integrity, and Response (ODSIR)
Offie of Compliance (OC)
CDER | FDA

Tom Ching
Regulatory Project Manager
DPM |ORO | OGD | CDER | FDA

Learn more at: https://www.fda.gov/drugs/news-events...

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