Recent questions tagged fda

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0 answers 604 views

FDA Draft Report & Plan on Best Practices for Guidance -- comments invited (by 3/4)

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

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0 answers 510 views

FDA Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Ads -- comments to OMB invited (by 1/22)

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

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0 answers 471 views

FDA Medical Devices Shortages Data Collections -- comments invited (by 1/29)

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

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0 answers 402 views

FDA Importation of Prescription Drugs data collection -- comments invited to OMB (by 11/20)

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

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0 answers 459 views

FDA Rapid Response Surveys -- comments on extension invited to OMB (by 10/2)

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

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0 answers 940 views

Using AI & ML in Development of Drug & Biological Products -- FDA invites comments on discussion paper (by 8/9)

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

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0 answers 436 views

Prescription Drug Promotion Research -- FDA invites comments to OMB on proposed tradeoff analysis (by 6/5)

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

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0 answers 434 views

Patient Experience Data -- FDA seeks info on methodological challenges to using (by 7/3)

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

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0 answers 531 views

Pharmaceutical Quality/Chemistry Manufacturing & Controls Data Elements/Terminologies -- FDA seeks input on draft (open)

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

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0 answers 605 views

Food Labeling in Online Grocery Shopping -- FDA seeks information (by 7/24)

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

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0 answers 729 views

FDA Data & Technology Strategic Plan -- request for information/comments (by 6/12)

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

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0 answers 728 views

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

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

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0 answers 595 views

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

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

0 votes

0 answers 1.1k views

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

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

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0 answers 856 views

Joint USPTO-FDA Collaboration Initiatives -- comments invited (3/10)

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

0 votes

0 answers 1.2k views

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

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

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0 answers 570 views

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

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

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0 answers 664 views

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

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

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0 answers 750 views

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

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

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0 answers 539 views

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

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

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0 answers 626 views

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

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

0 votes

0 answers 677 views

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

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

0 votes

0 answers 769 views

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

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

0 votes

0 answers 958 views

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

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

0 votes

0 answers 1k views

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

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

0 votes

0 answers 1.3k views

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)

0 votes

0 answers 604 views

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

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

0 votes

0 answers 1.1k views

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

asked 3 years ago by Andrew Reamer (58.3k points)

0 votes

0 answers 851 views

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

asked 3 years ago by Andrew Reamer (58.3k points)

0 votes

0 answers 1.1k views

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

asked 3 years ago by Andrew Reamer (58.3k points)

0 votes

0 answers 680 views

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

asked 3 years ago by Andrew Reamer (58.3k points)

0 votes

0 answers 741 views

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

asked 3 years ago by Andrew Reamer (58.3k points)

0 votes

0 answers 928 views

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

asked 3 years ago by Andrew Reamer (58.3k points)

0 votes

0 answers 926 views

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

asked 3 years ago by Andrew Reamer (58.3k points)

0 votes

0 answers 932 views

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

asked 3 years ago by Andrew Reamer (58.3k points)

0 votes

0 answers 666 views

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

asked 4 years ago by Andrew Reamer (58.3k points)

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