March 27, 2020

Regulatory Science at CDER

Regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. CDER’s regulatory science […]
March 26, 2020

Dr. Reddy’s Laboratories Issues Voluntary Nationwide Recall of Phytonadione Injectable Emulsion USP, 10 mg/mL Single-Dose Ampules Due To Ampules Breaking And Shattering Upon Opening

Summary Company Announcement Date: March 26, 2020 FDA Publish Date: March 26, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Ampules breaking & shattering […]
March 26, 2020

Q&A for Consumers: Hand Sanitizers and COVID-19

The FDA is working with U.S. government partners including the Centers for Disease Control and Prevention (CDC), medical product manufacturers, and international partners to address the […]
March 26, 2020

FDA notification regarding dehydrated alcohol

FDA notification regarding dehydrated alcohol FDA requested companies stop distributing unapproved versions of dehydrated alcohol. The agency approved Belcher Pharmaceuticals LLC’s Ablysinol (dehydrated alcohol), 1 mL […]
March 26, 2020

Partnerships and Collaborations

President’s Emergency Plan for AIDS Relief (PEPFAR) The U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) is the U.S. Government’s response to save the lives of […]
March 26, 2020

International Agreements & Information Sharing

The Food and Drug Administration (FDA) fosters partnerships with counterpart foreign government agencies and international organizations. The tools that FDA uses to set up and memorialize […]
March 26, 2020

International Regulatory Harmonization

Regulatory harmonization represents a process where regulatory authorities align technical requirements for the development and marketing of pharmaceutical products. Harmonization of regulatory requirements has many benefits […]
March 26, 2020

CDER International Program

The Center for Drug Evaluation and Research (CDER) has a mission to ensure the availability of safe and effective medicines to improve the health of people […]
March 25, 2020

Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments

Image Español 简体中文   한국어   Tagalog   Việt While many Americans are sheltering at home to help “flatten the curve” and slow the spread of […]
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