Recent questions tagged fda

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

asked 6 months ago by Andrew Reamer (57.8k points)

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0 answers 294 views

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

asked 7 months ago by Andrew Reamer (57.8k points)

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0 answers 251 views

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

asked 7 months ago by Andrew Reamer (57.8k points)

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0 answers 256 views

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

asked 9 months ago by Andrew Reamer (57.8k points)

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0 answers 301 views

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

asked 10 months ago by Andrew Reamer (57.8k points)

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0 answers 652 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 (57.8k points)

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0 answers 301 views

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

asked 1 year ago by Andrew Reamer (57.8k points)

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0 answers 311 views

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

asked 1 year ago by Andrew Reamer (57.8k points)

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0 answers 316 views

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

asked 1 year ago by Andrew Reamer (57.8k points)

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0 answers 298 views

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

asked 1 year ago by Andrew Reamer (57.8k points)

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0 answers 565 views

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

asked 1 year ago by Andrew Reamer (57.8k points)

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0 answers 578 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 (57.8k points)

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0 answers 459 views

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

asked 1 year ago by Andrew Reamer (57.8k points)

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0 answers 867 views

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

asked 1 year ago by Andrew Reamer (57.8k points)

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0 answers 698 views

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

asked 1 year ago by Andrew Reamer (57.8k points)

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0 answers 984 views

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

asked 1 year ago by Andrew Reamer (57.8k points)

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0 answers 447 views

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

asked 1 year ago by Andrew Reamer (57.8k points)

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0 answers 473 views

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

asked 1 year ago by Andrew Reamer (57.8k points)

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0 answers 533 views

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

asked 1 year ago by Andrew Reamer (57.8k points)

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0 answers 394 views

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

asked 1 year ago by Andrew Reamer (57.8k points)

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0 answers 429 views

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