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December 22, 2020

G & L Wellness, LLC – 609572 – 12/22/2020

Product: Animal & VeterinaryDrugs Recipient: Recipient Name Lois Carter Recipient Title President G & L Wellness, LLC 2231 14th St S 114Wisconsin Rapids, WI 54494United States […]
December 22, 2020

New Leaf Pharmaceuticals, LLC – 609744 – 12/22/2020

Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States RE: 609744 Dear Messrs. Carpenter & Deraney:       This […]
December 22, 2020

NextL3vel Services Group, LLC dba This Stuff Is Good For You – 610446 – 12/22/2020

Delivery Method: Via Email Product: Animal & VeterinaryDrugsFood & Beverages Recipient: Recipient Name Michael L. Cabarus and Ryan A. Rodriguez Recipient Title Managing Members NextL3vel Services […]
December 22, 2020

Wellness BioSciences Rx – 609604 – 12/22/2020

Delivery Method: Via Email Product: DrugsFood & Beverages Issuing Office: Center for Drug Evaluation and Research | CDER United States RE: 609604 Dear Mr. Cocheu:    This […]
December 22, 2020

Bee Delightful – 610689 – 12/22/2020

Delivery Method: VIA EMAIL AND UNITED PARCEL SERVICE Product: DrugsFood & Beverages Recipient: Recipient Name Skyler R. Johnstone Recipient Title Principal Bee Delightful (b)(6), (b)(7)(C)United States […]
December 22, 2020

Customceutical Compounding – 610092 – 08/25/2020

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Sarah K. Simmers, Pharm. D. Recipient Title Co-Owner, Pharmacist-in-Charge Customceutical Compounding 4611 East Shea Blvd., Building 3, […]
December 22, 2020

Rowpar Pharmaceuticals – 611759 – 12/18/2020

Product: Drugs Recipient: Recipient Name James Ratcliff Recipient Title CEO Rowpar Pharmaceuticals 16100 N. Greenway Hayden Loop #400Scottsdale, AZ 85260United States [email protected] [email protected] Date:               December […]
December 21, 2020

Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency Guidance for Industry

Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research FDA plays a critical role in protecting the United […]
December 21, 2020

FDA Approves Treatment for Ebola Virus

The U.S. Food and Drug Administration approved Ebanga (Ansuvimab-zykl), a human monoclonal antibody, for the treatment for Zaire ebolavirus (Ebolavirus) infection in adults and children. Ebanga […]
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