Recent questions tagged fda

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

asked 16 days ago by Andrew Reamer (43.7k points)

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0 answers 57 views

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

asked 22 days ago by Andrew Reamer (43.7k points)

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0 answers 44 views

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

asked 25 days ago by Andrew Reamer (43.7k points)

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0 answers 43 views

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

asked 28 days ago by Andrew Reamer (43.7k points)

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0 answers 54 views

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

asked 1 month ago by Andrew Reamer (43.7k points)

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0 answers 182 views

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

asked 1 month ago by Andrew Reamer (43.7k points)

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0 answers 297 views

Design/Conduct of Externally Controlled Trials for Drug/Biological Products draft guidance--FDA seeks comments (by 5/2)

asked 3 months ago by Andrew Reamer (43.7k points)

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0 answers 201 views

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

asked 3 months ago by Andrew Reamer (43.7k points)

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0 answers 344 views

Dosage/Administration Labeling for Prescription Drugs -- FDA invites comments on draft guidance (by 3/14)

asked 4 months ago by Andrew Reamer (43.7k points)

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0 answers 298 views

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

asked 6 months ago by Andrew Reamer (43.7k points)

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0 answers 482 views

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

asked 6 months ago by Andrew Reamer (43.7k points)

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0 answers 153 views

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

asked 6 months ago by Andrew Reamer (43.7k points)

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0 answers 201 views

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

asked 7 months ago by Andrew Reamer (43.7k points)

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0 answers 253 views

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

asked 7 months ago by Andrew Reamer (43.7k points)

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0 answers 158 views

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

asked 8 months ago by Andrew Reamer (43.7k points)

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0 answers 168 views

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

asked 10 months ago by Andrew Reamer (43.7k points)

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0 answers 210 views

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

asked 10 months ago by Andrew Reamer (43.7k points)

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0 answers 269 views

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

asked 10 months ago by Andrew Reamer (43.7k points)

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0 answers 584 views

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

asked 10 months ago by Andrew Reamer (43.7k points)

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0 answers 575 views

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

asked 10 months ago by Andrew Reamer (43.7k points)

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0 answers 633 views

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

asked 11 months ago by Andrew Reamer (43.7k points)

0 votes

0 answers 219 views

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