FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: CONSIDERATIONS FOR WAIVER REQUESTS FOR PH ADJUSTERS IN GENERIC DRUG PRODUCTS INTENDED FOR PARENTERAL, OPHTHALMIC, OR OTIC USE; GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, Nov. 17 -- Food and Drug Administration has issued a notice called: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use; Guidance for Industry; Availability.

The notice was published in the Federal Register on Nov. 17 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use." This guidance is intended to assist abbreviated new drug application (ANDA) applicants that ...