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October 18, 2022

American Cleaning Solutions – 632881 – 09/06/2022

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Mr. Ronald C. Ingber Recipient Title President American Cleaning Solutions 3930 Review Ave.Long Island City, NY 11101United […]
October 18, 2022

Beijing Xinggu Lvsan Technology Co., Ltd. Formerly known as Beijing Lvsan Technology Co., Ltd. – 633904 – 10/05/2022

Delivery Method: Certified Mail Product: Drugs Recipient: Recipient Name Mr. Shenxiang Zhai Recipient Title General Manager Beijing Xinggu Lvsan Technology Co., Ltd. Formerly known as Beijing […]
October 18, 2022

South Pork Ranch Equipment LLC – 642420 – 09/20/2022

Delivery Method: Via Email Product: Animal & VeterinaryDrugs Recipient: Recipient Name James Fuller Recipient Title eBay account: goatandchickenman South Pork Ranch Equipment LLC (b)(6)United States Issuing […]
October 17, 2022

Complex Generics News

Generally, complex generics are products that have complex active ingredients, formulations, dosage forms, or routes of administration, or are complex drug-device combination products. Generics of complex […]
October 17, 2022

Advances in FDA’s Drug Safety Programs

Drug Safety is A Key Priority at the Center for Drug Evaluation and Research Drug Safety Priorities 2021 (PDF – 10 MB) CDER Drug Safety Priorities 2021 is […]
October 17, 2022

What to Expect after an Inspection: 483s, Responses and Beyond – 12/14/2022

On This Page Date: December 14, 2022 Time: 2:00 PM – 3:00 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS WEBINAR During […]
October 17, 2022

Tissue Agnostic Drug Development in Oncology

Docket Number: FDA-2022-D-0286 Issued by: Guidance Issuing Office Oncology Center of Excellence Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance […]
October 17, 2022

Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials

Docket Number: FDA-2022-D-1744 Issued by: Guidance Issuing Office Oncology Center of Excellence Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Cancer immunotherapeutic […]
October 17, 2022

Rare Neurodegenerative Disease Grant Program

Rare Neurodegenerative Disease Grant Program FDA launched the FDA Rare Neurodegenerative Disease Grant Program when the Accelerating Access to Critical Therapies for ALS was enacted. The […]
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