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Concept
Generic Drug Approval
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Summary
Generic Drug Approval
is a
Regulatory Process
that allows for the
Production and sale of drugs
that are equivalent to
Brand-Name Drugs
in dosage, safety, strength,
Route Of Administration
, quality,
Performance Characteristics
, and
Intended Use
, but at a
Lower cost
. This process ensures that generic drugs meet the same rigorous standards as their brand-name counterparts, facilitating access to
Affordable medications
while maintaining
Public Health Safety
.
Concepts
Bioequivalence
Pharmaceutical Equivalence
Therapeutic Equivalence
Abbreviated New Drug Application (ANDA)
Hatch-Waxman Act
Drug Price Competition And Patent Term Restoration Act
FDA Approval Process
Patent Exclusivity
Regulatory Compliance
Public Health Policy
Regulatory Exclusivity
Pharmaceutical Registration
Data Exclusivity
Relevant Degrees
General and Professional Pharmacy 50%
Medicaments According to Principal Action 30%
Pharmaceutical Preparations and Equipment 20%
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