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Notice on Clinical Trial Monitoring Corrected

[ Price : $8.95]

Federal Register notice: FDA corrects a 4/12 notice about a final guidance entitled A Risk-Based Approach to Monitoring of Clinica...

Comments Sought on Patient Experience Data

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Federal Register notice: FDA creates a public docket to collect comments on methodological challenges related to patient experienc...

OPDP Research on Drug Adherence Software

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Federal Register notice: CDERs Office of Prescription Drug Promotion proposed to conduct a study on Perceptions of Prescription D...

ID Certification Under FOIA

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Federal Register notice: FDA sends OMB an information collection extension entitled Certification of Identity for Freedom of Infor...

FDA Finishes Posting OTC Drug Deemed Final Orders

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With the 5/2 posting of five deemed final orders, FDA completes the process of posting 33 deemed final orders that was part of ove...

FDA Partial Hold on Sun JAK Inhibitor Trial

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FDA issues a partial clinical hold on Sun Pharmas Deuruxolitinib (CTP-543), a JAK inhibitor being evaluated for treating alopecia ...

Astellas/Pfizer Mulling sNDA for Xtandi

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Astellas Pharma and Pfizer plan to discuss with FDA the filing of a supplemental NDA for Xtandi (enzalutamide) plus leuprolide for...

BMS Files for Reblozyl Expanded Use

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FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Reblozyl (luspatercept-aamt) that seeks an expanded in...

Bipartisan Bill on Preventing Drug Shortages

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Representatives Sara Jacobs (D-CA) and Cory Mills (R-FL) introduce bipartisan legislation to minimize and prevent future drug shor...

Complete Response on Hypoparathyroidism NDA

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FDA sends Ascendis Pharma a complete response letter on its NDA for TransCon PTH (palopegteriparatide), indicated for treating adu...