FDA is advising ANDA applicants to follow a tier-based approach in comparing the abuse deterrence of a generic product to the innovator product. Under this approach sponsors start in vitro testing with simple, gentle manipulations and "progress to complex and more destructive manipulations."
The agency's draft guidance on "General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products," says that generally, comparative in vitro and pharmacokinetic studies...