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The FDA should expand the use of comparability protocols to cover multiple products within a facility rather than limiting the use to document manufacturing changes to specific products, manufacturers told the agency in response to a draft guidance released in September.
The FDA should allow for reporting categories other than Prior Approval Supplements (PASs) for comparability protocols if tests and studies do not meet predefined acceptance criteria, PhRMA told the agency in comments on a draft guidance on the protocols.
For comparability protocols, the FDA should allow for reporting categories other than Prior Approval Supplements (PASs) if tests and studies do not meet predefined acceptance criteria, PhRMA told the agency in comments on a draft guidance on the protocols.