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April 6, 2020

FDA approves luspatercept-aamt for anemia in adults with MDS

On April 3, 2020, the Food and Drug Administration approved luspatercept-aamt (REBLOZYL, Celgene Corporation) for the treatment of anemia failing an erythropoiesis stimulating agent and requiring […]
April 3, 2020

Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act

Docket Number: FDA-2014-D-0329 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance is intended for entities […]
April 3, 2020

Anesthetic and Analgesic Drug Products 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 […]
April 3, 2020

Developing Antifungal Drugs for the Treatment of Coccidiodomycosis (Valley Fever) Infection – 08/05/2020 – 08/05/2020

On This Page Date: August 5, 2020 Time: 9:00 AM – 5:00 PM ET Onsite registration will start at 8:00 AM ET Summary  The FDA is […]
April 2, 2020

FDA Commissioned Corps Officers on the Front Line of COVID-19 Response

Image CaptionFDA Commissioned Corps officers practice fitting of protective items. By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs During this difficult time when everyday […]
April 2, 2020

Gaia’s Whole Healing Essentials, LLC – 605893 – 04/01/2020

Product: Drugs Recipient: Recipient Name Mr. Michael Lamboy Gaia’s Whole Healing Essentials, LLC 5 Alcedo CourtMoffat, CO 81143United States [email protected] Date:             April 1, 2020 RE:             […]
April 2, 2020

Homeomart Indibuy – 605888 – 04/01/2020

Product: Drugs Recipient: Recipient Name Mr. Vasant Prabhu Homeomart Indibuy #10, Ekta Arcade1 Main, 2nd A Cross, Sadashiv NagarBelgaum 590001KarnatakaIndia [email protected] Date:              April 1, 2020 RE: […]
April 2, 2020

Health Mastery Systems DBA Pure Plant Essentials – 605890 – 04/01/2020

Product: Drugs Recipient: Recipient Name Ms. KG Stiles Health Mastery Systems DBA Pure Plant Essentials 1654 Peachy RoadAshland, OR 97520United States [email protected] Date:              April 1, […]
April 2, 2020

Development Considerations of Antifungal Drugs to Address Unmet Medical Need – 08/04/2020 – 08/04/2020

On This Page Date: August 4, 2020 Time: 9:00 AM – 5:00 PM ET Attend Eventbrite Link Onsite registration will start at 8:00 AM ET Summary […]
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