NDA & ANDA PPT

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Its related to NDA & ANDA

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By: mrunalinibattu (111 month(s) ago)

good and simplified

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NDA & ANDA:

NDA & ANDA UDAY B. PAWAR M. Pharm. Pharmaceutics….

New Drug Development Process:

New Drug Development Process 2

Phases Of Clinical Testing:

Phases Of Clinical Testing 3

PowerPoint Presentation:

4

REQUIREMENTS:

REQUIREMENTS 5

New Drug Application (NDA) Classifications:

New Drug Application (NDA) Classifications New molecular entity New salt of previously approved drug (not a new molecular entity) New formulation of previously approved drug (not a new salt OR a new molecular entity) New combination of two or more drugs 6

New Drug Application (NDA) Classifications:

New Drug Application (NDA) Classifications 5. Already Marketed Drug Product – Duplication (i.e., new manufacturer) 6. New Indication (claim) for Already Marketed Drug ( includes switch in marketing status from prescription to OTC) 7. Already Marketed Drug Product – No previously Approved NDA 7

NDA PATHWAY:

NDA PATHWAY 8

NDA Review Process:

NDA Review Process 9

ANDA (Abbreviated New Drug Application):

ANDA (Abbreviated New Drug Application) A generic drug product is one that is comparable to an innovator drug product also known as the reference listed drug (RLD) product as identified in the FDA’s list of ( Approved Drug Products with Therapeutic Equivalence Evaluations ) in dosage form, strength, route of administration, quality, performance characteristics and intended use. 10

ANDA (Abbreviated New Drug Application):

ANDA (Abbreviated New Drug Application) “ANDA” is the abbreviation for Abbreviated New Drug Application. It contains data which when submitted to FDA’s CDER, office of generic drugs, provides for the review and ultimate approval of a generic drug product. Once approved an applicant may manufacture and market the generic drug product provided all issues related to patent protection and exclusivity associated with RLD have been resolved. 11

ANDA (Abbreviated New Drug Application):

ANDA (Abbreviated New Drug Application) Generic drug applications are termed “abbreviated” in that they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. These parameters were established upon the approval of the innovator drug product, which is the first version of the drug product approved by the FDA. 12

ANDA/AADA Review Process:

ANDA/AADA Review Process 13

ANDA pathway:

ANDA pathway 14

CERTIFICATION:

CERTIFICATION 15

PowerPoint Presentation:

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PowerPoint Presentation:

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