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May 25, 2022

Compounding Quality Center of Excellence Annual Conference – 09/06/2022

On This Page Date: September 6 – 8, 2022 Time: 8:00 AM – 4:00 PM ET Location: Virtual Conference Subscribe to be alerted when registration opens This […]
May 25, 2022

Importation of Prescription Drugs Final Rule Questions and Answers; Small Entity Compliance Guide

Docket Number: FDA-2021-D-0958 Issued by: Guidance Issuing Office Office of Regulatory Affairs This guidance is intended to help small entities better understand the final rule, “Importation […]
May 24, 2022

Electronic Certificates of Pharmaceutical Product: General Information

Facilities exporting human drugs are often asked by foreign customers or foreign governments to provide documentation of the facility’s compliance with FDA standards. FDA issues export […]
May 24, 2022

Ayuryoga, Inc. – 628168 – 05/19/2022

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Nikhil Gupta Ayuryoga, Inc. 332 Springtown RoadNew Paltz, NY 12561United States [email protected] Issuing Office: Center for Drug […]
May 24, 2022

Santhigram Kerala Ayurvedic Co. of U.S., Inc. – 625892 – 05/19/2022

Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States Dear Mr. Nair: This letter is to advise […]
May 24, 2022

Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers (Revision 1)

Submit Comments by 07/24/2022 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 […]
May 24, 2022

PETNET Solutions Inc. – 584016 – 05/17/2022

Product: Drugs Recipient: Recipient Name Mr. Barry Scott Recipient Title Chief Executive Officer PETNET Solutions Inc. 810 Innovation DriveKnoxville, TN 37932United States Issuing Office: Division of […]
May 24, 2022

PETNET Solutions Inc. – 584016 – 10/17/2019

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Barry Scott Recipient Title Chief Executive Officer PETNET Solutions Inc. 810 Innovation DriveKnoxville, TN 37932United States […]
May 23, 2022

Regulatory Health Project Manager Jobs in CDER

Description of duties Manage the drug review process for one or more classes of drugs. Plan, focus and coordinate team activities within the Division. Plan and […]
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