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October 6, 2020

FDA to compounders: Know Your Bulks Supplier

FDA has identified several issues over the past few years related to repackers of bulk drug substances, also called active pharmaceutical ingredients (APIs), used to compound […]
October 6, 2020

DDT COA #000024: Pediatric Eosinophilic Esophagitis (EoE) Symptom Severity Module (PEESS™ v2.0)

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Immunology and Inflammation (OII)Division of Gastroenterology (DG) DDT COA NumberDDT COA #000024 Instrument NamePediatric Eosinophilic Esophagitis (EoE) Score (PEES™ […]
October 6, 2020

DDT COA #000092: PROMIS® Pediatric Crohn’s Disease Short Form – Fatigue 10

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Immunology and Inflammation (OII)Division of Gastroenterology (DG) DDT COA NumberDDT COA #000092 Instrument NamePROMIS® Pediatric Crohn’s Disease Short Form […]
October 6, 2020

DDT COA #000076: TUMMY-CD

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Immunology and Inflammation (OII)Division of Gastroenterology (DG) DDT COA NumberDDT COA #000076 Instrument NameTUMMY-CD Disease/ConditionCrohn’s disease (CD) Concept of […]
October 6, 2020

DDT COA #000034: Crohn’s Disease Patient-Reported Outcomes Signs and Symptoms (CD-PRO/SS)

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Immunology and Inflammation (OII)Division of Gastroenterology (DG) DDT COA NumberDDT COA #000034 Instrument NameCrohn’s Disease Patient-Reported Outcomes Signs and […]
October 6, 2020

DDT COA #000015: PROMIS® Short Form Fatigue 10a in Rheumatoid Arthritis

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Immunology and Inflammation (OII)Division of Rheumatology and Transplant Medicine (DRTM) DDT COA NumberDDT COA #000015 Instrument NamePROMIS® Short Form […]
October 6, 2020

DDT COA #000027: A Tool to Assess Quality of Life in Idiopathic Pulmonary Fibrosis (ATAQ-IPF)

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Immunology and Inflammation (OII)Division of Pulmonary, Allergy, and Critical Care (DPACC) DDT COA NumberDDT COA #000027 Instrument NameA Tool […]
October 6, 2020

DDT COA #000080: PROMIS® Fatigue Item Bank for ME/CFS/SEID

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Immunology and Inflammation (OII)Division of Rheumatology and Transplant Medicine (DRTM) DDT COA NumberDDT COA #000080 Instrument NamePROMIS® Fatigue Item […]
October 5, 2020

Marksans Pharma Limited Issues Expansion of Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg & 750mg, Due to the Detection of N-Nitrosodimethylamine (NDMA)

Summary Company Announcement Date: October 02, 2020 FDA Publish Date: October 05, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to the Detection […]
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