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Annual Study

by | Mar 26, 2025 | News

Sign up for Compounding and Compounding Quality Center of Excellence EmailsThe FDA Compounding Quality Center of Excellence conducts the Compounding Outsourcing Facilities Annual Study to better understand industry perspectives and challenges, as well as dynamics...

NIH Funded Pediatric Labeling Changes

by | Mar 26, 2025 | News

AcyclovirUpdate Dosage and Administration, Clinical Pharmacology, and Adverse Reactions sections of the label with information that dosing for neonatal HSV should be based on postmenstrual age (PMA) at doses higher than those included in the acyclovir label at the...

Sovereign Laboratories, LLC – 606490

by | Mar 26, 2025 | News

Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN) United States Federal Trade Commission Date:              June 15, 2020 RE:                 Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)   This is to advise you...

Healthcare Providers (Biologics)

by | Mar 26, 2025 | News

Image Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. The Center for Biologics Evaluation and Research (CBER) is responsible for...

Project 1600 Inc. – 608349

by | Mar 26, 2025 | News

Recipient: Recipient Name Dennis Michael Lynch Project 1600 Inc. 501 Montauk HwyBox 704Amagansett, NY 11930United States WeTrustDML@gmail.com Issuing Office: Center for Drug Evaluation and Research | CDER United States Federal Trade Commission Date:               June...

Consumers (Biologics)

by | Mar 26, 2025 | News

Image Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Content current as of: 03/25/2025 Regulated Product(s) Topic(s)...

North Isle Wellness Center – 607947

by | Mar 26, 2025 | News

Issuing Office: Center for Drug Evaluation and Research | CDER United States Federal Trade Commission WARNING LETTER   Date:               June 19, 2020 RE:                  Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to...

Resources for You (Biologics)

by | Mar 25, 2025 | News

Image Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex...