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April 12, 2022

Generitech Corporation – 618333 – 03/01/2022

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mrs. Norma D. Daliva-Banks Recipient Title President Generitech Corporation 4967 E Lansing WayFresno, CA 93727-7408United States Issuing […]
April 11, 2022

OPDP Regulatory Information

Laws, Regulations, Guidances, and Compliance Actions Some of the links from this page take you to other government web sites. Once you leave this page, click […]
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 […]
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