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Recent

Countries Step Up to Tackle Antimicrobial Resistance

Jul 18, 2018

AHE Announces Winners of 2018 Environmental Services Department of the Year Award

Jul 18, 2018

A Polio-Free U.S. Thanks to Vaccine Efforts

Jul 18, 2018

New York-Based Food Processors Agree to Stop Food Preparation Operations Due to Food Safety Violations

Jul 18, 2018

Outbreak of Salmonella Infections Linked to Hy-Vee Spring Pasta Salad

Jul 18, 2018

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Featured

PPE Donning and Doffing Reveals Gaps in Knowledge and Practice

Jul 12, 2018

Cleanliness and Sterility Assurance in Central Sterile and the Operating Room

Jul 12, 2018

IPs Meet the SPD: Why You Should Partner to Reduce Risk

Jul 12, 2018

Maintaining a Sufficient Level of Reprocessing Equipment

Jul 12, 2018

Highlights

New York-Based Food Processors Agree to Stop Food Preparation Operations Due to Food Safety Violations

Jul 18, 2018

Two New York-based food processing companies have agreed to stop preparing food products, which include a variety of ready-to-eat foods...

FDA Approves the First Drug With an Indication for Treatment of Smallpox

Jul 13, 2018

The Food and Drug Administration (FDA) today approved TPOXX (tecovirimat), the first drug with an indication for...

FDA Updates Warnings for Fluoroquinolones on Risks of Mental Health and Low Blood Sugar Adverse Reactions

Jul 11, 2018

The Food and Drug Administration (FDA) today is requiring safety labeling changes for a class of antibiotics...

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FDA Permits Marketing of First Catheter-Based Systems Used to Create Vascular Access for Hemodialysis Patients

Jun 25, 2018

Today, the Food and Drug Administration (FDA) permitted marketing of two catheter-based devices designed to create a connection to veins and arteries in patients with chronic kidney disease who need hemodialysis...

FDA Issues Statement on Efforts to Foster Discovery and Development of New Tools to Fight Antimicrobial-Resistant Infections

Jun 12, 2018

FDA Commissioner Scott Gottlieb, MD, has issued the following statement: "The increase in serious antimicrobial drug resistant infections is a critical public health concern and a growing threat to patients. According to our colleagues at the...

FDA Seeks Injunction Against Company Selling Unapproved Hand Sanitizers That Claim to Prevent Infections From Numerous Pathogens

Jun 07, 2018

The Food and Drug Administration (FDA) today filed a complaint against Innovative BioDefense, Inc. of Lake Forest, Calif., and Colette Cozean, the company’s president and chief executive officer, to prohibit them from selling Zylast topical...

FDA Approves First Biosimilar to Neulasta to Help Reduce the Risk of Infection During Cancer Treatment

Jun 05, 2018

The Food and Drug Administration (FDA) announces it has approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other...

NIOSH and FDA Collaboration Streamlines Regulatory Oversight for N95 Filtering Facepiece Respirators

May 18, 2018

Previously, N95 filtering facepiece respirators (N95) used in healthcare needed approval from both the National Institute for...

FDA Issues Medical Device Safety Action Plan

May 08, 2018

The Center for Devices and Radiological Health (CDRH)’s vision for medical device safety is to protect patients and spur...

FDA Authorizes First Test to Identify Candida auris

Apr 23, 2018

The Food and Drug Administration (FDA) announces it has authorized the first test to identify the emerging pathogen Candida...

FDA Orders Mandatory Recall for Kratom Products Due to Salmonella Risk

Apr 04, 2018

The Food and Drug Administration (FDA) announces it has issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several were found to contain...

Commissioner Addresses Key Step in Advancing FDA’s Oversight of Drug Compounding

Mar 23, 2018

Food and Drug Administration (FDA) commissioner Scott Gottlieb, MD, has issed a statement on the FDA’s oversight of drug compounding and implementing new laws...

FDA Warns Duodenoscope Manufacturers About Failure to Comply With Postmarket Surveillance Studies to Assess Contamination

Mar 12, 2018

The Food and Drug Administration (FDA) has issued warning letters to all three duodenoscope manufacturers for failing to comply with requirements of federal law under which they were ordered to conduct postmarket surveillance studies to assess the...

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