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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 […]
October 5, 2020

CDER proposes withdrawal of approval for Makena

[10/5/2020] Today, the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) proposed that Makena (hydroxyprogesterone caproate injection) be withdrawn from the market […]
October 5, 2020

Makena (hydroxyprogesterone caproate injection) Information

CDER Statement 10/5/2020 – CDER proposes withdrawal of approval for Makena The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) proposed that […]
October 5, 2020

Clinical Outcome Assessments (COA) Qualification Program Submissions

The tables below list information about submissions to the FDA Clinical Outcome Assessments (COA) Qualification Program for which final COA qualification determinations have not yet been […]
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