RLD: An RLD is the specific listed drug on which an ANDA applicant relies in seeking approval for its ANDA. The ANDA applicant must show, among other things, that its proposed generic drug is the same as to the RLD with respect to the active ingredient(s), dosage form, route of administration, strength, labeling and conditions of use.
RS: A reference standard is a drug product selected by FDA for use as a comparator in in vivo bioequivalence studies to support ANDA approval. The reference standard should be comparable to the RLD with respect to active ingredient(s), dosage form, route of administration, strength, labeling, and conditions of use.
FDA identifies listed drugs that are eligible to be RLDs in the Orange Book. A listed drug that appears in the Discontinued Section in the Orange Book may be eligible to be an RLD, unless FDA makes a determination that the listed drug was withdrawn from the market for reasons of safety or effectiveness.
Potential ANDA applicant can request FDA to designate an RLD or a different RLD when RLD is no longer exists. FDA may designate a RS in cases where the RLD is no longer marketed, or if the RLD has been subject to certain changes that may affect its bioequivalence, such as a change in manufacturing site or formulation.
Basis of Submission: The basis of submission refers to the RLD and the RS, if applicable, that an ANDA applicant relies on in its submission to demonstrate that its proposed generic drug is the same as the RLD and bioequivalent to the RS.
Refer USFDA guideline "Referencing Approved Drug Products in ANDA Submissions" for more details.
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Resource Person: Bharathi Kodali
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