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Robert J. Hayashi, M.D./Washington University School of Medicine, Department of Pediatrics - 654873 - 03/14/2023
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202
FDA
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Tyrone L. McCall, M.D./Cornea Associates of Texas - 651261 - 03/22/2023
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267
FDA
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Jarman’s Midwest Cleaning Systems, Inc. Issues Voluntary Nationwide Recall of Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solut
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370
FDA
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NIH Funded Pediatric Labeling Changes for drugs studied under the 409i process
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268
FDA
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Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program
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220
FDA
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Drug Master File (DMF) Submission Resources
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211
FDA
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Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 March 2023, CVMP, 24/03/2023
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247
EMA
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FDA Updates and Press Announcements on NDMA in Zantac (ranitidine)
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216
FDA
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GDUFA Implementation Quarterly Meetings between FDA and Industry
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205
FDA
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Drug Compounding and Drug Shortages
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224
FDA
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FDA approves first treatment for activated phosphoinositide 3-kinase delta syndrome
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269
FDA
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FDA’s Dosage and Administration Section of Labeling Draft Guidance - 04/19/2023
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409
FDA
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Electronic Systems, Electronic Records, and Electronic Signatures Webinar - 04/25/2023
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246
FDA
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Biomarker Qualification Submissions
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193
FDA
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FDA grants accelerated approval to retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma
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266
FDA
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Electronic Common Technical Document (eCTD)
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212
FDA
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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-Nitrosod
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241
FDA
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Advancing regulatory science in the EU – mid-point report published, , 22/03/2023
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336
EMA
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Biosimilar Basics for Patients
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213
FDA
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Inter-governmental Working Meeting on Drug Compounding | November 1-2, 2022
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208
FDA
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