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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. […]
June 30, 2020

Auro Pharmacies, Inc., dba Central Drugs Compounding Pharmacy – 608369 – 06/03/2020

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Nayan Patel, Pharm.D. Recipient Title President Auro Pharmacies, Inc., dba Central Drugs Compounding Pharmacy 520 W. La […]
June 30, 2020

FDA approves pembrolizumab for first-line treatment of MSI-H/dMMR colorectal cancer

On June 29, 2020, the Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co.) for the first-line treatment of patients with unresectable or metastatic microsatellite […]
June 29, 2020

Coronavirus (COVID-19) Update: Daily Roundup June 29, 2020

For Immediate Release: June 29, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
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