Recent questions tagged fda

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0 answers 32 views

Human Nonprescription Drug Product Labeling Content/Format -- FDA invites comment on draft industry guidance (by 11/8)

asked 17 days ago by Andrew Reamer (30.5k points)

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0 answers 77 views

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

asked 2 months ago by Andrew Reamer (30.5k points)

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0 answers 101 views

Drug Supply Chain Security Act: Drug Tracing Info Exchange Stds -- FDA proposes industry guidance (comment by 9/6)

asked 2 months ago by Andrew Reamer (30.5k points)

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0 answers 106 views

Drug Supply Chain Security Act: Identifying Trading Partners -- FDA proposes industry guidance (comment by 9/6)

asked 2 months ago by Andrew Reamer (30.5k points)

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0 answers 268 views

Patient-Focused Drug Development -- Guidance 3 for industry -- FDA invites comments on draft (by 9/28)

asked 2 months ago by Andrew Reamer (30.5k points)

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0 answers 196 views

Nonprescription Drug Product w/ Additional Condition for Nonprescription Use -- FDA invites input on rule (by 10/26)

asked 2 months ago by Andrew Reamer (30.5k points)

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0 answers 230 views

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

asked 3 months ago by Andrew Reamer (30.5k points)

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0 answers 117 views

Prescription Drug Promotion Research -- FDA invites comments on proposed tradeoff analysis (by 6/24)

asked 5 months ago by Andrew Reamer (30.5k points)

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0 answers 300 views

FDA Quality Metrics Reporting Program -- comments invited on proposed changes (by 6/7)

asked 6 months ago by Andrew Reamer (30.5k points)

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0 answers 224 views

Drug Supply Chain Security Act -- FDA invites comment on 2 draft rules on wholesale distributors (by 4/5 and 9/6)

asked 7 months ago by Andrew Reamer (30.5k points)

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0 answers 309 views

Drug Supply Chain Security Act illegitimate product notification - FDA invites comments to OMB on proposal (by 2/25)

asked 7 months ago by Andrew Reamer (30.5k points)

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0 answers 154 views

FDA Guidance for Industry: Data Standards for Drug/Biological Product Submissions -- comments on draft invited (by 2/4)

asked 9 months ago by Andrew Reamer (30.5k points)

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0 answers 181 views

FDA Guidance for Industry on Use of EHRs/Med Claims to Support Reg Decisions -- comments invited on draft (by 1/24)

asked 9 months ago by Andrew Reamer (30.5k points)

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0 answers 208 views

FDA Guidance for Industry on Use of Data/Evidence to Support Reg Decisions -- comments invited on draft (by 3/9)

asked 9 months ago by Andrew Reamer (30.5k points)

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0 answers 283 views

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

asked 9 months ago by Andrew Reamer (30.5k points)

0 votes

0 answers 234 views

Enhancing Safety/Security of Pharma Distribution Supply Chain -- FDA public mtg (11/16), seeks comments (by 1/18)

asked 11 months ago by Andrew Reamer (30.5k points)

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0 answers 256 views

Health economists -- FDA Office of Women's Health seeks input on strategic research priorities (by 9/8)

asked 2 years ago by Andrew Reamer (30.5k points)