FDA Offers Guidelines on pH Waivers for Liquid Generic Drugs

The FDA has released a draft guidance on waiver requests for pH adjusters in generic drug products for parenteral, ophthalmic and otic uses.

The agency said the waiver approach is strongly recommended in cases where the inactive ingredient requirements aren’t met due to the presence of one or more pH adjusters.

Waivers are possible when there is a difference between the generic drug and the reference product as long as the difference does not change the generic’s final attributes or its performance, the agency said.

The deadline for comment on the draft document is June 13.

Read the draft guidance here: bit.ly/3rNpVyT.