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April 8, 2022

CofixRx, LLC – 626860 – 04/05/2022

Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States WARNING LETTER Date: April 05, 2022 RE: Unapproved New Drug Products Related […]
April 8, 2022

I. Shay Cosmetics Inc – 552754 – 12/29/2021

Delivery Method: VIA EMAIL CONFIRMED DELIVERY Product: Drugs Recipient: Recipient Name Mr. Mehdi Ehsan Recipient Title President/CEO I. Shay Cosmetics Inc 1024 E Del Amo BlvdCarson, […]
April 8, 2022

I. Shay Cosmetics Inc – 552754 – 10/29/2018

WARNING LETTER VIA SIGNATURE CONFIRMED DELIVERY October 29, 2018 Mr. Mehdi EhsanCEO and OwnerI. Shay Cosmetics Inc.1024 East Del Amo BoulevardCarson, California 90746 Dear Mr. Ehsan: […]
April 7, 2022

eCTD Important Notices

Notice 8/30/2021FDA FR Notice on high severity eCTD validations 1551&1553 Notice 8/25/2021FDA FR Notice on high severity eCTD validations 1306&1323   Notice 6/23/2021FDA eCTD v4.0 Validation […]
April 7, 2022

US-Canada Regional ICH Consultation – 05/11/2022

On This Page Date: May 11, 2022 Time: 1:00 PM – 4:00 PM ET Agenda Visit CDER Small Business and Industry Assistance Page ABOUT THIS MEETING […]
April 7, 2022

Sensory Cloud, Inc – 628897 – 04/06/2022

Product: Drugs Recipient: Recipient Name David Edwards Sensory Cloud, Inc 214 Cambridge Street Suite 400Boston, MA 02114United States [email protected] Issuing Office: Center for Drug Evaluation and […]
April 7, 2022

Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers

Submit Comments by 06/07/2022 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 […]
April 6, 2022

FDA Workshop on the Role of Phytosterols in PNALD/IFALD – 05/06/2022

On This Page Date: May 6, 2022 Time: 9:30 AM – 4:30 PM ET Visit CDER Small Business and Industry Assistance Page Agenda ABOUT THIS WORKSHOP […]
April 6, 2022

FDA approves alpelisib for PIK3CA-related overgrowth spectrum

On April 5, 2022, the Food and Drug Administration granted accelerated approval to alpelisib (Vijoice, Novartis Pharmaceuticals) for adult and pediatric patients two years of age […]
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