> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Wants Comments on Generic Guidances
- URL: https://www.fdaweb.com/fda-wants-comments-on-generic-guidances/
- Published: 2017-07-13T12:00:00.000Z
- Updated: 2026-09-14T22:33:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139125

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](ttps://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm075207.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) 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.