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March 21, 2023

Dunagin Pharmaceuticals Inc. dba Massco Dental – 644335 – 02/22/2023

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Michael Sean Dunagin Recipient Title Owner Dunagin Pharmaceuticals Inc. dba Massco Dental 1506 N. 2nd […]
March 21, 2023

Herbal Vitality, Inc. – 640206 – 03/07/2023

Delivery Method: VIA UPS Product: DrugsFood & Beverages Recipient: Recipient Name Yvan P. Rochon, PhD Recipient Title President Herbal Vitality, Inc. 2810 Hopi DrSedona, AZ 86336-3733United […]
March 20, 2023

Vita Pharmacy, LLC dba Talon Pharmacy of Boerne – 639220 – 08/29/2022

Product: Drugs Recipient: Recipient Name Praful Patel Recipient Title Co-Owner Vita Pharmacy, LLC dba Talon Pharmacy of Boerne 5900 Balcones Dr, STE 100Austin, TX 78731United States […]
March 17, 2023

Pharmacogenomic Data Submissions

Submit Comments by 06/20/2023 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
March 17, 2023

Creating a Roadmap to Quantitative Systems Pharmacology-Informed Rare Disease Drug Development – 05/11/2023

On This Page Date: May 11, 2023 Time: 10:00 AM – 5:00 PM ET About this Virtual Workshop: The U.S. Food and Drug Administration (FDA) in […]
March 16, 2023

FDA approves dabrafenib with trametinib for pediatric patients with low-grade glioma with a BRAF V600E mutation

On March 16, 2023, the Food and Drug Administration approved dabrafenib (Tafinlar, Novartis) with trametinib (Mekinist, Novartis) for pediatric patients 1 year of age and older […]
March 16, 2023

Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program

What is the CDRP CDRP aims to: Facilitate the expedited CMC development of products with expedited clinical development timeframes. Increase communication between FDA and sponsors. Provide […]
March 16, 2023

Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry

Docket Number: FDA-2018-D-0338 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Drug Supply Chain Security Act […]
March 15, 2023

Development of Local Anesthetic Drug Products With Prolonged Duration of Effect

Submit Comments by 06/14/2023 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
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