New FDA Draft Guidance Reduces Reporting Requirements for Certain Postapproval Manufacturing Changes

The US Food and Drug Administration has issued a new draft guidance regarding the types of manufacturing changes that can be reported in annual reports. The guidance lists 44 postapproval manufacturing changes that now may be reported in annual reports instead of supplements, because the changes are considered to be of low risk to product quality.

Examples of the listed changes include:

* the elimination or reduction of an overage from the drug product manufacturing batch formula

* changes to filtration process parameters

* changes in the approved analytical procedure if the revisions do not change the acceptance criteria

* replacement of …