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August 23, 2021

Three-Dimensional (3D) Cell Culture (Microphysiological) Platforms as Drug Development Tools

CDER researchers are investigating cell culture platforms that can supplant the need for animal testing or clinical trials in specific regulatory contexts. These platforms recreate three-dimensional […]
August 20, 2021

FDA Export Certification

Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Center for Devices and Radiological Health Center for Food […]
August 20, 2021

FDA approves nivolumab for adjuvant treatment of urothelial carcinoma

On August 19, 2021, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Co.) for the adjuvant treatment of patients with urothelial carcinoma (UC) who […]
August 20, 2021

Impact of Continuous Manufacturing Processes on the Viral Safety of Therapeutic Proteins

CDER researchers are working to ensure the safety of therapeutic proteins produced by continuous manufacturing. Shifting Therapeutic Protein Drug Substance Manufacturing Paradigms The manufacture of therapeutic […]
August 20, 2021

Mahita, LLC dba PushMyCart – 616541 – 08/19/2021

Product: Drugs WARNING LETTER Date: August 19, 2021 RE: Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the […]
August 20, 2021

Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application

Docket Number: FDA-2013-D-1464 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA) is announcing the availability of a […]
August 19, 2021

ICU Medical, Inc. Issues a Voluntary Nationwide Recall of Lactated Ringer’s Injection, USP and 0.9% Sodium Chloride Injection, USP Due to Presence of Particulate Matter

Summary Company Announcement Date: October 30, 2019 FDA Publish Date: October 30, 2019 Product Type: Animal & VeterinaryDrugs Reason for Announcement: Recall Reason Description Due to […]
August 19, 2021

Advancing Our Understanding of How Drug Promotion Influences Consumers and Health Care Providers

CDER researchers are exploring the development of validated instruments to measure perceptions of direct-to-consumer drug advertisements, investigating the effects of imagery in these ads, and uncovering […]
August 18, 2021

Public Notification: Themra Epimedyumlu Bitkisel Karisimli Macun contains hidden drug ingredient

[8-18-2021] The Food and Drug Administration is advising consumers not to purchase or use Themra Epimedyumlu Bitkisel Karisimli Macun, a product promoted for sexual enhancement and […]
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