Recent questions tagged fda

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0 answers 489 views

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

asked 11 months ago by Andrew Reamer (58.3k points)

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0 answers 406 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 383 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 344 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 397 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 787 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 368 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 366 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 428 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 424 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 640 views

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

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

0 votes

0 answers 640 views

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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0 answers 523 views

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

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

0 votes

0 answers 954 views

Dosage/Administration Labeling for Prescription Drugs -- FDA invites comments on draft guidance (by 3/14)

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

0 votes

0 answers 772 views

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

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

0 votes

0 answers 1.1k 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 518 views

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

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

0 votes

0 answers 557 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)

0 votes

0 answers 606 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)

0 votes

0 answers 468 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)

0 votes

0 answers 544 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 607 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 684 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 908 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 932 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 1.1k 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 538 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 1k views

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

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

0 votes

0 answers 787 views

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

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

0 votes

0 answers 966 views

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

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

0 votes

0 answers 528 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 676 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 773 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 835 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 853 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 590 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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