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June 30, 2020

Arthritis 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 […]
June 30, 2020

DDT COA #000102: Physical Activity Accelerometry Assessment for Analgesic Clinical Trials (PAACT)

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Neuroscience (ON)Division of Anesthesia, Addiction Medicine, and Pain Medicine (DAAP) DDT COA NumberDDT COA #000102 Instrument NamePhysical Activity Accelerometry […]
June 30, 2020

DDT COA #000106: Actibelt® in Multiple Sclerosis

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Neuroscience (ON)Division of Neurology II (DN II) DDT COA NumberDDT COA #000106 Instrument NameActibelt® in Multiple Sclerosis Disease/ConditionMultiple Sclerosis […]
June 30, 2020

DDT COA #000103: ActiMyo®

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Neuroscience (ON)Division of Neurology I (DN I) DDT COA NumberDDT COA #000103 Instrument NameActiMyo® Disease/ConditionDuchenne Muscular Dystrophy (DMD) Concept […]
June 30, 2020

DDT COA #000105: Actibelt® in Sarcopenia

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Cardiology, Hematology, Endocrinology, and Nephrology (OCHEN)Division of General Endocrinology (DGE) DDT COA NumberDDT COA #000105 Instrument NameActibelt® in Sarcopenia […]
June 30, 2020

DDT COA #000114: Chronic Heart Failure- Activity Monitor-Based Endpoint Measure

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Cardiology, Hematology, Endocrinology, and Nephrology (OCHEN)Division of Cardiovascular and Nephrology (DCN) DDT COA NumberDDT COA #000114 Instrument NameChronic Heart […]
June 30, 2020

Homeocare Laboratories, Inc. – 603532 – 06/22/2020

Delivery Method: Certified Mail Product: Drugs Recipient: Recipient Name Ms. Edith Scheiner Recipient Title President Homeocare Laboratories, Inc. 7 Odell Plaza Suite 142-146Yonkers, NY 10701United States […]
June 30, 2020

Malanda, Inc. dba Mandell’s Clinical Pharmacy – 608320 – 06/09/2020

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Teresa Malanda, RPh. Recipient Title Pharmacist/Owner Malanda, Inc. dba Mandell’s Clinical Pharmacy 7 Cedar Grove Lane, Suite […]
June 30, 2020

Only Natural, Inc. dba Bio Nutrition, Inc. – 605076 – 06/18/2020

Product: DrugsFood & Beverages Recipient: Recipient Name Mr. Robert M. LoMacchio Recipient Title President and CEO Only Natural, Inc. dba Bio Nutrition, Inc. 3580 Oceanside Rd. […]
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