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Recent questions tagged fda
0
votes
0
answers
493
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)
fda
0
votes
0
answers
407
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)
fda
prescription-drugs
0
votes
0
answers
385
views
FDA Medical Devices Shortages Data Collections -- comments invited (by 1/29)
asked
1 year
ago
by
Andrew Reamer
(
58.3k
points)
fda
medical-device-shortages
0
votes
0
answers
345
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)
fda
prescription-drugs
0
votes
0
answers
398
views
FDA Rapid Response Surveys -- comments on extension invited to OMB (by 10/2)
asked
1 year
ago
by
Andrew Reamer
(
58.3k
points)
fda
0
votes
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)
fda
artificial-intelligence
machine-learning
drug-development
0
votes
0
answers
369
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)
fda
prescription-drugs
0
votes
0
answers
367
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)
fda
patient-experience-data
0
votes
0
answers
430
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)
fda
pq
cmc
pharmaceuticals
0
votes
0
answers
425
views
Food Labeling in Online Grocery Shopping -- FDA seeks information (by 7/24)
asked
1 year
ago
by
Andrew Reamer
(
58.3k
points)
fda
online-groceries
nutrition-labels
0
votes
0
answers
642
views
FDA Data & Technology Strategic Plan -- request for information/comments (by 6/12)
asked
1 year
ago
by
Andrew Reamer
(
58.3k
points)
fda
0
votes
0
answers
642
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Design/Conduct of Externally Controlled Trials for Drug/Biological Products draft guidance--FDA seeks comments (by 5/2)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)
fda
clinical-trials
drugs
0
votes
0
answers
524
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)
fda
food-labeling
0
votes
0
answers
955
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)
fda
prescription-drugs
0
votes
0
answers
774
views
Joint USPTO-FDA Collaboration Initiatives -- comments invited (3/10)
asked
2 years
ago
by
Andrew Reamer
(
58.3k
points)
uspto
fda
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)
fda
drug-supply-chain
0
votes
0
answers
519
views
FDA: Advancing Premarket Safety Analytics -- comments invited (by 12/5)
asked
2 years
ago
by
Andrew Reamer
(
58.3k
points)
fda
0
votes
0
answers
559
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)
fda
drug-manufacturing
0
votes
0
answers
608
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)
fda
medical-devices
0
votes
0
answers
470
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)
fda
nonprescription-drugs
0
votes
0
answers
546
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)
fda
drugs
0
votes
0
answers
609
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)
fda
drug-supply-chain
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)
fda
drug-supply-chain
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)
fda
drug-development
0
votes
0
answers
935
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)
fda
nonprescription-drugs
0
votes
0
answers
1.2k
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)
fda
drugs
0
votes
0
answers
539
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)
fda
prescription-drugs
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)
fda
quality-metrics-drug-manufacturing
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)
fda
drug-supply-chain
0
votes
0
answers
967
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)
fda
drug-supply-chain
0
votes
0
answers
531
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)
fda
0
votes
0
answers
677
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)
fda
electronic-health-records
medical-claims
evidence
0
votes
0
answers
774
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)
fda
evidence
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)
fda
drugs
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)
fda
drug-supply-chain
prescription-drugs
0
votes
0
answers
591
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)
fda
womens-health
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