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IRB Individual Patient Expanded Access Reviews Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance on IRB reviews of individual patient expanded access requests.

Antibody Test Validation Data Posted

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FDA posts test performance data from four antibody test kits from an independent performance validation study effort with the Nati...

AlgoTherapeutix ATX01 Orphan Drug Status

[ Price : $8.95]

FDA grants AlgoTherapeutix an orphan drug designation for ATX01 (topical amitriptyline) for treating erythromelalgia.

Revised EUA Bans China Decontaminated Respirators

[ Price : $8.95]

FDA reissues certain emergency use authorizations to identify specific respirators that can be decontaminated for reuse.

42% of FDA Drug Quality Inspections Done in U.S.

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A new FDA drug quality annual report finds that the agency in 2019 performed 1,258 drug quality surveillance inspections, with 42%...

Farley Appointed FDA Antimicrobial Products Director

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CDER Office of Antimicrobial Products deputy director John Farley is named permanent director.

FDA Relaxes Drug Sample Enforcement

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FDA posts a guidance on a temporary Policy to make it easier for drug firms to distribute drug samples During the Covid-19 public ...

Abiomed Small Heart Pump Study Approved

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FDA approves an Abiomed IDE to start an early feasibility study with a first-in-human trial of the 9 French Impella Expandable Car...

PDUFA Reauthorization Virtual Meeting

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Federal Register notice: FDA announces a 7/23 virtual public meeting on Reauthorization of the Prescription Drug User Fee Act.

Electronic Signatures Addressed in Clinical Trial Q&A

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FDA adds a new section to a clinical trial guidance that discusses 21 CFR Part 11 compliance for electronic systems used to genera...