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September 27, 2022

Zhejiang Tianyu Pharmaceutical Co., Ltd. – 631054 – 08/17/2022

Delivery Method: Return Receipt Requested Product: Drugs Recipient: Recipient Name Mr. Yongjun Tu Recipient Title Chief Executive Officer and Chairman of the Board Zhejiang Tianyu Pharmaceutical […]
September 27, 2022

Muscle Sports Products, LLC – 625731 – 09/23/2022

Delivery Method: United Parcel Service Product: DrugsFood & Beverages Recipient: Recipient Name Jason R. Mancuso Recipient Title CEO Muscle Sports Products, LLC 101 Dominion Blvd.Ronkonkoma, NY […]
September 27, 2022

System Kosmetik Produktionsgesellschaft fur kosmetische Gmbh – 632727 – 09/09/2022

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Ms. Petra Mikschl Recipient Title Chief Executive Officer/Co-owner System Kosmetik Produktionsgesellschaft fur kosmetische Gmbh Raiffeisenstr. 2Munster86692 […]
September 27, 2022

Providing Over-the-Counter Monograph Submissions in Electronic Format

Submit Comments by 11/28/2022 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 […]
September 26, 2022

Walfer Corporation dba Wallace Pharmacy – 611017 – 09/20/2022

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Wayne Wallace Recipient Title Owner Walfer Corporation dba Wallace Pharmacy 3524 B Tamiami TrailPort Charlotte, FL 33952-8100United […]
September 23, 2022

Ethical Considerations for Clinical Investigations of Medical Products Involving Children

Issued by: Guidance Issuing Office Office of the Commissioner, Office of Clinical Policy and Programs, Office of Pediatric Therapeutics Center for Biologics Evaluation and Research Center […]
September 23, 2022

FDA Issues New Guidance to Help Facilitate Availability of Naloxone to Prevent Opioid Overdoses and Reduce Death

Image By: Marta Sokolowska, Ph.D., Deputy Center Director for Substance Use and Behavioral Health, Center for Drug Evaluation and Research On August 30, 2022, Commissioner Robert […]
September 23, 2022

Guidance Recap Podcast | Ethical Considerations for Clinical Investigations of Medical Products Involving Children

Thank you for joining us for another episode of the Guidance Recap Podcast. My name is Kylie Haskins, and I am today’s host. In this episode, […]
September 22, 2022

Data Standards Catalog v8.2

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Download the Final Guidance Submit Comments Submit comments on this guidance document electronically via docket […]
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