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December 7, 2022

Efficacy of Monoclonal Antibodies in the Context of Rapidly Evolving SARS-CoV-2 Variants – 12/15/2022

On This Page Date: December 15, 2022 Time: 13:00-17:00 Central European Time | 7:00 AM-11:00 AM United States EST OBJECTIVES This meeting will be held in virtual format […]
December 7, 2022

Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry

Docket Number: FDA-2017-D-6580 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance describes how we intend […]
December 6, 2022

Compounding Outsourcing Facilities Annual Study

Background Since 2019, the FDA Compounding Quality Center of Excellence has conducted the Compounding Outsourcing Facilities Annual Study to better understand industry perspectives and challenges, as […]
December 6, 2022

Peripheral and Central Nervous System Drugs 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 […]
December 6, 2022

Kari Gran Inc. – 640035 – 11/30/2022

Delivery Method: VIA EMAIL CONFIRMED DELIVERY Product: Drugs Recipient: Recipient Name Ms. Kari R. Gran Recipient Title President and Co-founder Kari Gran Inc. 1735 Westlake Ave […]
December 6, 2022

Glenmark Pharmaceuticals Limited – 637314 – 11/22/2022

Delivery Method: Return Receipt Requested Product: Drugs Recipient: Recipient Name Mr. Glenn Saldanha Recipient Title Chairman and Managing Director Glenmark Pharmaceuticals Limited Glenmark House, B D […]
December 6, 2022

AG Hair Limited – 638646 – 11/28/2022

Delivery Method: VIA UPS Reference #: 320-23-05 Product: Drugs Recipient: Recipient Name Mr. Graham Fraser Recipient Title CEO AG Hair Limited 14 King Edward StreetCoquitlam BC […]
December 2, 2022

Drug Trial Snapshot: AMONDYS 45

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]
December 2, 2022

ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions

Docket Number: FDA-2017-D-3101 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Pharmaceutical Quality The Food and Drug Administration (FDA) is issuing […]
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