FDA Wants Comments on Generic Guidances

FDA says it wants feedback on 34 product-specific guidances that describe the agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference-listed drugs (RLDs). The 21 new and 13 revised product-specific guidances are listed with the docket soliciting feedback.

The docket notice says that generic drug applicants “should consider that their product is expected to be: pharmaceutically equivalent to its reference-listed drug, i.e., to have the same active ingredient, dosage form, strength, and route of administration under the same conditions of use; bioequivalent to the RLD, i.e., to show no significant difference in the rate and extent of absorption of the active pharmaceutical ingredient; and, consequently, therapeutically equivalent, i.e., to be substitutable for the RLD with the expectation that the generic product will have the same safety and efficacy as the RLD.