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March 24, 2023
Published by Med Search on March 24, 2023
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FDA approves first treatment for activated phosphoinositide 3-kinase delta syndrome

Action FDA has approved Joenja (leniolisib) tablets as the first treatment for activated phosphoinositide 3-kinase delta syndrome in adult and pediatric patients 12 years of age […]
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March 24, 2023
Published by Med Search on March 24, 2023
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Drug Safety and Risk Management Advisory Committee Roster

Applying for Membership on FDA Advisory Committees As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of […]
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March 24, 2023
Published by Med Search on March 24, 2023
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Drug Compounding and Drug Shortages

What is a compounded drug? Drug compounding is often regarded as the process of combining, mixing, or altering ingredients to create a medication tailored to the […]
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March 24, 2023
Published by Med Search on March 24, 2023
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FDA Updates and Press Announcements on NDMA in Zantac (ranitidine)

Update [1/8/2020] The U.S. Food and Drug Administration is alerting health care professionals and consumers to Mylan’s voluntary recall of prescription nizatidine capsules. The medicines may […]
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March 22, 2023
Published by Med Search on March 22, 2023
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Ascend Laboratories LLC. Issues Voluntary Nationwide Recall of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

Summary Company Announcement Date: March 22, 2023 FDA Publish Date: March 22, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Detection of N-Nitrosodimethylamine (NDMA) […]
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March 22, 2023
Published by Med Search on March 22, 2023
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Electronic Systems, Electronic Records, and Electronic Signatures Webinar – 04/25/2023

On This Page Date: April 25, 2023 Time: 3:00 PM – 4:30 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS WEBINAR As […]
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March 22, 2023
Published by Med Search on March 22, 2023
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Biomarker Qualification Submissions

Requestor Abbreviated Biomarker Description Abbreviated COU *Qualification Submission & Reviewable Date FDA Submission Decision & Recommendations DDTBMQ000006 Menarini Silicon Biosystems Inc. / Memorial Sloan Kettering Cancer […]
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March 22, 2023
Published by Med Search on March 22, 2023
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FDA grants accelerated approval to retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma

On March 22, 2023, the Food and Drug Administration granted accelerated approval to retifanlimab-dlwr (Zynyz, Incyte Corporation) for adult patients with metastatic or recurrent locally advanced […]
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March 22, 2023
Published by Med Search on March 22, 2023
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Electronic Common Technical Document (eCTD)

Quick Links Notices The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and […]
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