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Clinical Electronic Structured Protocol Template

[ Price : $8.95]

FDA publishes for reference only an International Council for Harmonization template on a clinical electronic structured harmonize...

Comments on Increasing Access to Non-Prescription Drugs

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Four stakeholders comment to FDA on ways to increase patient access to nonprescription drugs.

FDA to Convene Panel on Modernas mRNA Flu Vaccine

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FDA announces a 6/18 advisory committee meeting to review Modernas controversial mRNA-based seasonal influenza vaccine.

RFK Jr. Ignores Hill Request on Anti-Vax Activist HHS Role

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HHS secretary Robert F. Kennedy Jr. faces renewed scrutiny from Senate Democrats for ignoring requests about the role of longtime ...

Lilly Says Retatrutide Delivered Up to 30% Weight Loss

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Eli Lilly reports that its investigational obesity drug retatrutide produced weight-loss results approaching those historically as...

All India Institute Clinical Trial Issues

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FDA warns Dr. Sourav Mishra about violations in his conduct of a clinical investigation at the All India Institute of Medical Scie...

Naseem Jaffrani BIMO Violation

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FDA warns Alexandria, LA-based cardiologist Naseem Jaffrani about his failure to conduct a clinical investigation according to the...

Will the Next Commissioner Learn from Makarys Mistakes?

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Former FDA associate commissioner Peter Pitts says FDA has an opportunity with the resignation of commissioner Marty Makary to res...

FDA Has to Build CRISPR Edit Review Protocol

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A Clinical Trial Vanguard post describes the issues facing FDA in determining how to review and approve a BLA for a one-time CRISP...

Guidance on Drug Food Effects Studies

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FDA publishes a guidance with recommendations for sponsors planning to submit food-effect studies for INDs or NDAs.