ANDA submission to USFDA

An abbreviated new drug application (ANDA) is a generic product application to the USFDA. After approval, applicants can manufacture and market these drugs in the US. All approved products, both innovator and generic are listed in the orange book of FDA. US-FDA granted 833 final ANDA approvals in the year 2019. Additionally, 146 Tentative Approvals were also granted during the calendar year 2019. In terms of regional trends, Indian companies continued to dominate with 374 or around 44 per cent of final approvals, followed by US, EU and then China.

Category: Crash Courses
Duration : Training duration: 7.5 hours, course would be accessible for 1 month from the date of admission

Learning objectives

FDA, CDER, GDUFA, DUNS, NDC, Self identification, drug establishment, types of applications, US patents scenario, ANDA submission modules, labeling, ANDA review & approval

Eligibility

B.Pharm/M.Pharm/M.Sc/B.Sc/MBA/ PhD/ Working professionals from Pharma/Bio-tech industry [QC/QA/R & D/F & D/ ADL/ RA/ Patents/International business etc] & those aspiring to enhance their regulatory affairs knowledge.

Anyone willing to understand this topic can enroll.

Syllabus

  • Section 1:

    • CDER, US agent, DUNS, FEI number, Self identification, GDUFA, Drug Establishment registration, NDC, Drug listing 132 minutes
    • Types of applications, patents overview 112 minutes
    • ANDA modules, labeling, submissions 118 minutes
    • ANDA review & approval 87 minutes

Fees : 5192

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    Course Include :
  • Video
  • PDF
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