Onkar ANDA ppt, spectroscopy, analysis, research
- 4. Applicant: An applicant means any person (usually a pharmaceutical firm) who submits an abbreviated new drug application, or an amendment or supplement to them, to obtain FDA approval to market a generic drug product. Acceptable & Complete? Upon receipt of the application a pre-filling assessment of its completeness & acceptability is performed by a project manager within the regulatory support branch, Office of Generic Drugs. Refuse to file letter issued: If the application is missing one or more essential components, a “Refuse to File” letter is sent to the applicant.
- 5. • Bioequivalence Review: • Applicants may request a waiver from performing in vivo bioequivalence studies for certain drug products where bioavailability may be demonstrated by submitting data such as: 1) a formulation comparison for products whose bioavailability is self evident 2) comparative dissolution. Chemistry/Microbiology Review: Areas such as the applicant’s manufacturing procedures, raw material specifications & controls, sterilization process, container & closure systems, accelerated & room temperature stability data are reviewed to assure that the drug will perform in an acceptable manner.
- 6. Labeling Review: It serves to identify & resolve issues that may contribute to medication errors such as similar sounding or appearing drug names, & the legibility or prominence of the name or strength. Bioequivalence Review Acceptable?: bioequivalence Deficiency Letter is issued by the division of Bioequivalence to the applicant. This deficiency letter details the deficiencies & requests information & data to resolve them.
- 7. • Chemistry/Microbiology/Labeling Review Acceptable?: Deficiencies are communicated to the applicant in a facsimile. The facsimile instructs the applicant to provide information & data to address the deficiencies. Pre-approval Inspection Acceptable?: The pre-approval inspection determines compliance with cGMPs as well as a product specific evaluation concerning the manufacturing process of the application involved. ANDA Approved: If the approval occurs prior to the expiration of any patents , a tentative approval letter is issued to the applicant which details the circumstances associated with the tentative approval of the generic drug product & delays approval until all patent/exclusivity issues have expired.
- 8. REFERENCES: • 1. New Drug Approval Process, Richard Gaurino, Marcel DekkerINC, New York, 2nd Edition, Vol.56, 189-212. • 2. www.fda.gov.