Recent questions tagged fda

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Design/Conduct of Externally Controlled Trials for Drug/Biological Products draft guidance--FDA seeks comments (by 5/2)

asked 7 hours ago by Andrew Reamer (38.6k points)

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0 answers 61 views

Quantitative Research on Front-of-Package Labeling on Packaged Foods--FDA invites comment (by 3/27)

asked 6 days ago by Andrew Reamer (38.6k points)

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0 answers 119 views

Dosage/Administration Labeling for Prescription Drugs -- FDA invites comments on draft guidance (by 3/14)

asked 19 days ago by Andrew Reamer (38.6k points)

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0 answers 157 views

Joint USPTO-FDA Collaboration Initiatives -- public listening session (1/19), comments invited (2/6)

asked 2 months ago by Andrew Reamer (38.6k points)

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0 answers 328 views

2023 Drug Supply Chain Security Act Implementation/Readiness Efforts -- FDA holds mtg (12/7-8), seeks input (by 2/6)

asked 2 months ago by Andrew Reamer (38.6k points)

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0 answers 82 views

FDA: Advancing Premarket Safety Analytics -- comments invited (by 12/5)

asked 2 months ago by Andrew Reamer (38.6k points)

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0 answers 124 views

Drugs Distributed Manufacturing and Point-of-Care Manufacturing -- FDA seeks comments (by 12/13)

asked 3 months ago by Andrew Reamer (38.6k points)

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0 answers 186 views

FDA Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot -- comments invited on design (by 1/10)

asked 3 months ago by Andrew Reamer (38.6k points)

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0 answers 104 views

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

asked 4 months ago by Andrew Reamer (38.6k points)

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0 answers 115 views

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

asked 6 months ago by Andrew Reamer (38.6k points)

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0 answers 145 views

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

asked 6 months ago by Andrew Reamer (38.6k points)

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0 answers 182 views

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

asked 6 months ago by Andrew Reamer (38.6k points)

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0 answers 479 views

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

asked 7 months ago by Andrew Reamer (38.6k points)

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0 answers 477 views

Nonprescription Drug Product w/ Additional Condition for Nonprescription Use -- FDA invites input on rule (by 11/25)

asked 7 months ago by Andrew Reamer (38.6k points)

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0 answers 537 views

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

asked 7 months ago by Andrew Reamer (38.6k points)

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0 answers 171 views

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

asked 9 months ago by Andrew Reamer (38.6k points)

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0 answers 515 views

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

asked 10 months ago by Andrew Reamer (38.6k points)

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0 answers 286 views

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

asked 11 months ago by Andrew Reamer (38.6k points)

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0 answers 504 views

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