Recent questions tagged drugs

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Design/Conduct of Externally Controlled Trials for Drug/Biological Products draft guidance--FDA seeks comments (by 5/2)

asked 1 year ago by Andrew Reamer (58.3k points)

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Medicare Drug Rebate/Negotiations Group created in HHS Center for Medicare (10.8.22)

asked 2 years ago by Andrew Reamer (58.3k points)

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Evaluation of Therapeutic Equivalence -- FDA invites comment on draft industry guidance (by 9/19)

asked 2 years ago by Andrew Reamer (58.3k points)

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Drug Quality Risk Management -- FDA invites comments on draft ICH guidance for industry (by 7/15)

asked 2 years ago by Andrew Reamer (58.3k points)

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FDA Guidance for Industry on Assessing Registries to Support Reg Decisions -- comments invited on draft (by 2/28)

asked 2 years ago by Andrew Reamer (58.3k points)

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