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

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

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

376. Regulatory classification of pharmaceutical co-crystals

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

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

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