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4672. Health document submission requirements for tobacco products: (revised)

4673. Registration and product listing for owners and operators of domestic tobacco product establishments: (revised)

4674. BCG-unresponsive nonmuscle invasive bladder cancer: developing drugs and biologics for treatment

4675. Regulatory classification of pharmaceutical co-crystals

4676. Duchenne muscular dystrophy and related dystrophinopathies: developing drugs for treatment

4677. How to prepare a pre-request for designation (pre-RFD)

4679. Q11 development and manufacture of drug substances (chemical entities and biotechnological/biological entities): questions and answers

4680. E6(R2) good clinical practice: integrated addendum to ICH E6(R1)