USA Archives - Page 4 of 7

USA | FDA Announces New Funding Opportunity for Using Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making
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USA | FDA Announces New Funding Opportunity for Using Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making

2022, December 2022, Members-Only, Moderate Update, RWD to Support Reg Decisions, USA

USA | FDA Announces New Funding Opportunity for Using Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making

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USA | FDA Announces New Funding Opportunity for Using Real-World Data to Generate Real-World Evidence in Regulatory Decision-Makingstuart.mccully2023-01-06T14:48:13+00:00

USA | Revised FDA Guidance on Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers
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USA | Revised FDA Guidance on Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers

2022, Members-Only, Moderate Update, November 2022, USA

USA | Revised FDA Guidance on Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers

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USA | Revised FDA Guidance on Expanded Access to Investigational Drugs for Treatment Use: Questions and Answersstuart.mccully2022-12-17T09:35:06+00:00

USA | New FDA Guidance on the Content of Human Factors (Usability) Information in Medical Device Marketing Submissions
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USA | New FDA Guidance on the Content of Human Factors (Usability) Information in Medical Device Marketing Submissions

2022, Medical Devices, Members-Only, Moderate Update, November 2022, USA

USA | New FDA Guidance on the Content of Human Factors (Usability) Information in Medical Device Marketing Submissions

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USA | New FDA Guidance on the Content of Human Factors (Usability) Information in Medical Device Marketing Submissionsstuart.mccully2022-12-17T09:39:22+00:00

USA | FDA RFI for Literature and Survey Study on Brain Computer-Interface Focused Research in Patients with ALS
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USA | FDA RFI for Literature and Survey Study on Brain Computer-Interface Focused Research in Patients with ALS

2022, Members-Only, October 2022, Rare Diseases, USA

USA | FDA RFI for Literature and Survey Study on Brain Computer-Interface Focused Research in Patients with ALS

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USA | FDA RFI for Literature and Survey Study on Brain Computer-Interface Focused Research in Patients with ALSstuart.mccully2022-11-14T17:39:46+00:00

USA | FDA Launches Pilot Program to Support Rare Disease Drug Development
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USA | FDA Launches Pilot Program to Support Rare Disease Drug Development

2022, Members-Only, October 2022, Rare Diseases, USA

USA | FDA Launches Pilot Program to Support Rare Disease Drug Development

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USA | FDA Launches Pilot Program to Support Rare Disease Drug Developmentstuart.mccully2022-11-14T17:21:32+00:00

USA | FDA Publishes Final Guidance on Procedures for Handling Post-Approval Studies Imposed by PMA Order
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USA | FDA Publishes Final Guidance on Procedures for Handling Post-Approval Studies Imposed by PMA Order

2022, Medical Devices, Members-Only, USA

USA | FDA Publishes Final Guidance on Procedures for Handling Post-Approval Studies Imposed by PMA Order

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USA | FDA Publishes Final Guidance on Procedures for Handling Post-Approval Studies Imposed by PMA Orderstuart.mccully2022-11-14T16:49:14+00:00

USA | FDA Publishes Final Guidance for Medical Device Postmarket Surveillance (522 Order)
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USA | FDA Publishes Final Guidance for Medical Device Postmarket Surveillance (522 Order)

2022, Medical Devices, Members-Only, October 2022, USA

USA | FDA Publishes Final Guidance for Medical Device Postmarket Surveillance (522 Order)

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USA | FDA Publishes Final Guidance for Medical Device Postmarket Surveillance (522 Order)stuart.mccully2022-11-14T16:44:40+00:00

USA | FDA Announces New Advancing RWE Program
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USA | FDA Announces New Advancing RWE Program

2022, Members-Only, October 2022, RWD to Support Reg Decisions, USA

USA | FDA Announces New Advancing RWE Program

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USA | FDA Announces New Advancing RWE Programstuart.mccully2022-11-14T16:35:19+00:00

USA | FDA Releases Draft Version of ICH E11A
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USA | FDA Releases Draft Version of ICH E11A

2022, August 2022, Members-Only, USA

USA | FDA Releases Draft Version of ICH E11A

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USA | FDA Releases Draft Version of ICH E11Astuart.mccully2022-09-12T11:07:14+00:00

USA | FDA Finalises Guidance on Identifying When RWD/RWE Used in Submission
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USA | FDA Finalises Guidance on Identifying When RWD/RWE Used in Submission

2022, August 2022, Members-Only, RWD to Support Reg Decisions, USA

USA | FDA Finalises Guidance on Identifying When RWD/RWE Used in Submission

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USA | FDA Finalises Guidance on Identifying When RWD/RWE Used in Submissionstuart.mccully2022-09-12T09:18:44+00:00

USA | FDA Announces New Funding Opportunity for Using Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making

USA | Revised FDA Guidance on Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers

USA | New FDA Guidance on the Content of Human Factors (Usability) Information in Medical Device Marketing Submissions

USA | FDA RFI for Literature and Survey Study on Brain Computer-Interface Focused Research in Patients with ALS

USA | FDA Launches Pilot Program to Support Rare Disease Drug Development

USA | FDA Publishes Final Guidance on Procedures for Handling Post-Approval Studies Imposed by PMA Order

USA | FDA Publishes Final Guidance for Medical Device Postmarket Surveillance (522 Order)

USA | FDA Announces New Advancing RWE Program

USA | FDA Releases Draft Version of ICH E11A

USA | FDA Finalises Guidance on Identifying When RWD/RWE Used in Submission

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