PHARM D
V YEAR NOTES
CLINICAL RESEARCH
2. Clinical development of drug:
Abbreviated New Drug Application submission / ANDA
Pharm D notes
The acronym "ANDA" stands for "Abbreviated New Drug Application." When submitted to the FDA's Center for Drug Evaluation & Research, Office of Generic Drug, it comprises information that allows enabling the evaluation and final authorization of a generic medicine product.
Once accepted, a candidate may produce and market the generic.
Drug product offered complete patent protection concerns, was secure, and a viable, affordable alternative for the general population.
Applications for generic medications are "abbreviated" because they are Preclinical (animal) and clinical research are typically not required.
To establish safety and effectiveness, we need (human) data.
A generic medication is one that is similar to an innovative drug.
product dose, potency, delivery method, and quality performance traits and intended use.
The FDA's list of approved products, including innovator and generic, Licensed Drug
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