US FDA News: FDA Approves First Treatment for Acid Sphingomyelinase Deficiency, a Rare Genetic Disease

The FDA approved Xenpozyme (Olipudase alfa) for intravenous infusion in pediatric and adult patients with Acid Sphingomyelinase Deficiency (ASMD), a rare genetic disease that causes premature death.
Read more: FDA Approves First Treatment for Acid Sphingomyelinase Deficiency, a Rare Genetic Disease

US FDA News: Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose

The FDA amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination.
Read more: Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose

US FDA News: FDA Roundup: August 30, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: August 30, 2022

US FDA News: Hamilton Medical AG Recalls Hamilton-C6 Intensive Care Ventilator Due to Potential Water Ingress that May Cause Breathing Support to Stop

If water enters the Hamilton-C6 Intensive Care Ventilator due to a loose status indicator board, it may cause the ventilator to stop providing breathing support.
Read more: Hamilton Medical AG Recalls Hamilton-C6 Intensive Care Ventilator Due to Potential Water Ingress that May Cause Breathing Support to Stop

US FDA News: Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue: FDA Safety Communication

Philips Respironics recalled certain BiPAP machines due to a plastic issue that may release certain chemicals of concern and cause device failure.
Read more: Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue: FDA Safety Communication

US FDA News: Intera Oncology Recalls Intera 3000 Hepatic Artery Infusion Pump Due to Faster Than Expected Flow Rates That May Impact Infusion Delivery

The Intera 3000 Hepatic Artery Infusion Pump is being recalled after reports that it has a faster than expected flow rate.
Read more: Intera Oncology Recalls Intera 3000 Hepatic Artery Infusion Pump Due to Faster Than Expected Flow Rates That May Impact Infusion Delivery

US FDA News: FDA Roundup: August 26, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: August 26, 2022

US FDA News: FDA Removes N95 Respirators from Medical Device Shortage List, Signaling Sufficient Supply

Today, the FDA announced the removal of N95 respirators from the agency’s medical device shortage list.
Read more: FDA Removes N95 Respirators from Medical Device Shortage List, Signaling Sufficient Supply

US FDA News: Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities

The FDA revoked the emergency use authorizations for non-NIOSH-approved disposable respirators and the EUAs for decontamination and bioburden reduction systems.
Read more: Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities

US FDA News: FDA and Mexican Counterparts Report Progress in Food Safety at Second Annual Partnership Meeting

Today, the U.S. Food and Drug Administration and its regulatory counterparts in Mexico COFEPRIS and SENASICA held the second annual Food Safety Partnership Meeting.
Read more: FDA and Mexican Counterparts Report Progress in Food Safety at Second Annual Partnership Meeting

US FDA News: Medtronic Recalls HeartWare HVAD System Batteries for Electrical Faults That Cause Battery Failure

An electrical fault may cause the batteries of the HeartWare HVAD System to fail, leading to severe injury or death.


Read more: Medtronic Recalls HeartWare HVAD System Batteries for Electrical Faults That Cause Battery Failure

US FDA News: FDA Roundup: August 23, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: August 23, 2022

US FDA News: Hospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion (Containing Benzyl Alcohol), Due To The Potential Presence of Visible Particulates

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Propofol Injectable Emulsion (containing benzyl alcohol), 100mL Single Patient Use Glass Fliptop Vial; lot EA7470, to the user level due to visible particulates observed in two vials during annual examination of retention samples.
Read more: Hospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion (Containing Benzyl Alcohol), Due To The Potential Presence of Visible Particulates

US FDA News: FDA Roundup: August 19, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: August 19, 2022

US FDA News: Medtronic Recalls Cobalt XT, Cobalt and Crome ICDs and CRT-Ds for Risk that Devices May Issue a Short Circuit Alert and Deliver Reduced Energy Shock During High Voltage Therapy

Cobalt/Crome ICDs and CRT-Ds may deliver reduced-energy electric shocks and short circuit protection (SCP) alerts during high voltage therapy.
Read more: Medtronic Recalls Cobalt XT, Cobalt and Crome ICDs and CRT-Ds for Risk that Devices May Issue a Short Circuit Alert and Deliver Reduced Energy Shock During High Voltage Therapy

US FDA News: 2022 Letters to Health Care Providers

The FDA posts letters to health care providers about the safe use of medical devices.
Read more: 2022 Letters to Health Care Providers

US FDA News: FDA Warns Manufacturer for Marketing Illegal Flavored Nicotine Gummies

Today, the U.S. Food and Drug Administration issued a warning letter for marketing illegal flavored nicotine gummies – the first warning letter for this type of product.
Read more: FDA Warns Manufacturer for Marketing Illegal Flavored Nicotine Gummies

US FDA News: FDA Approves First Cell-Based Gene Therapy to Treat Adult and Pediatric Patients with Beta-thalassemia Who Require Regular Blood Transfusions

FDA approves Zynteglo (betibeglogene autotemcel), the first cell-based gene therapy for the treatment of adult and pediatric patients with Beta-thalassemia who require regular red blood cell (RBC) transfusions.
Read more: FDA Approves First Cell-Based Gene Therapy to Treat Adult and Pediatric Patients with Beta-thalassemia Who Require Regular Blood Transfusions

US FDA News: Stop Using Certain Syringes and Needles with Needle Safety Devices Manufactured by Haiou – Letter to Health Care Providers

Certain syringes and needles with needle safety devices manufactured by HAIOU may cause needles to detach in patients’ arms after injection or needle failure.
Read more: Stop Using Certain Syringes and Needles with Needle Safety Devices Manufactured by Haiou – Letter to Health Care Providers

US FDA News: FDA Roundup: August 16, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: August 16, 2022

US FDA News: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls

Find answers to frequently asked questions on Philips Respironics ventilators, BiPAP, and CPAP machines recall
Read more: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls

US FDA News: Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication

This update provides additional information on the recall and recommendations for people who use repaired and replaced devices.
Read more: Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication

US FDA News: FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans

FDA issues historic final rule to improve access to affordable hearing aids for millions of Americans with perceived mild to moderate hearing impairment.
Read more: FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans

US FDA News: FDA Roundup: August 12, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: August 12, 2022

US FDA News: At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication

The FDA recommends repeat testing following a negative result to reduce the risk that a COVID-19 infection could be missed, whether or not you have symptoms.
Read more: At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication

US FDA News: Becton Dickinson Recalls Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits, and Intraosseous Powered Drivers for Issues That May Cause Delayed Treatment Delivery

Issues with BD Intraosseous needle kits and drivers may prevent treatments from being infused through the bone causing delays in care.
Read more: Becton Dickinson Recalls Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits, and Intraosseous Powered Drivers for Issues That May Cause Delayed Treatment Delivery

US FDA News: FDA Infant Formula Update: August 10, 2022

FDA exercises enforcement discretion to Reckitt Nutrition/Mead Johnson Nutrition to import Base Powder for PurAmino Hypoallergenic Infant Formula (amino acid-based infant formula with iron) infant formula products from Mexico following review of nutritional adequacy and safety information, including
Read more: FDA Infant Formula Update: August 10, 2022

US FDA News: Monkeypox Update: FDA Authorizes Emergency Use of JYNNEOS Vaccine to Increase Vaccine Supply

The FDA issued an emergency use authorization (EUA) for the JYNNEOS vaccine to increase vaccine supply by up to five-fold and to allow for individuals under 18 years of age determined to be at high risk of monkeypox infection to receive the vaccine.
Read more: Monkeypox Update: FDA Authorizes Emergency Use of JYNNEOS Vaccine to Increase Vaccine Supply

US FDA News: FDA Roundup: August 9, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: August 9, 2022

US FDA News: Haimen Shengbang Laboratory Equipment Co. Ltd. Recalls Viral Transport Media Containers That Are Not Authorized, Cleared, or Approved by the FDA

Haimen Shengbang is recalling Viral Transport Media Containers because they were distributed to U.S. customers without FDA authorization, clearance, or approval.
Read more: Haimen Shengbang Laboratory Equipment Co. Ltd. Recalls Viral Transport Media Containers That Are Not Authorized, Cleared, or Approved by the FDA

US FDA News: FDA Issues Warning Letters to Three Companies for Selling Unapproved New Drugs for Mole and Skin Tag Removal

Today, the FDA issued three warning letters to companies for introducing products for mole and skin tag removal into interstate commerce that are unapproved new drugs.
Read more: FDA Issues Warning Letters to Three Companies for Selling Unapproved New Drugs for Mole and Skin Tag Removal

US FDA News: FDA Roundup: August 5, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: August 5, 2022

US FDA News: FDA Infant Formula Update: August 5, 2022

FDA Infant Formula Update: August 5 Nestlé (The Netherlands)
Read more: FDA Infant Formula Update: August 5, 2022

US FDA News: FDA Approves First Targeted Therapy for HER2-Low Breast Cancer

FDA Approves First Targeted Therapy for HER2-Low Breast Cancer
Read more: FDA Approves First Targeted Therapy for HER2-Low Breast Cancer

US FDA News: VI-Jon, LLC Expands Voluntary Worldwide Recall of All Flavors and Lots within Expiry of Magnesium Citrate Saline Laxative Oral Solution Due to Microbial Contamination

Vi-Jon, LLC is revising a previously reported list of all flavors of Magnesium Citrate Saline Laxative Oral Solution within expiry
Read more: VI-Jon, LLC Expands Voluntary Worldwide Recall of All Flavors and Lots within Expiry of Magnesium Citrate Saline Laxative Oral Solution Due to Microbial Contamination

US FDA News: Plastikon Healthcare Expands Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum Hydroxide /Simethicone Oral Suspension Due to Microbial Contamination

Plastikon Healthcare, LLC is issuing an update to the voluntary recall initiated on June 3, 2022. The recall has been expanded to include Lot 20076A of Magnesium Hydroxide 1200 mg / Aluminum Hydroxide 1200 mg / Simethicone 120 mg per 30 mL Oral Suspension. This lot was previously subject to a retai
Read more: Plastikon Healthcare Expands Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum Hydroxide /Simethicone Oral Suspension Due to Microbial Contamination

US FDA News: FDA Continues Efforts to Support Innovation in Medical Device Sterilization

The FDA provides updates on its work to promote innovative ways to sterilize medical devices while reducing adverse impacts on the environment and on the public health, but also developing solutions to avoid potential shortages of medical devices.
Read more: FDA Continues Efforts to Support Innovation in Medical Device Sterilization

US FDA News: Distributor RFR, LLC, Voluntary Nationwide Recall of Sangter Energy Supplement Due to Presence of Undeclared Sildenafil

Miami, Florida, DISTRIBUTOR RFR, LLC. is voluntarily recalling lot #48656, Exp. 01/2025 of SANGTER Energy Supplement, 3000 mg, packaged in 7-count blister packs within a carton to the consumer level. FDA analysis has found the product to contain undeclared sildenafil. Sildenafil is a phosphodiestera
Read more: Distributor RFR, LLC, Voluntary Nationwide Recall of Sangter Energy Supplement Due to Presence of Undeclared Sildenafil

US FDA News: FDA Roundup: August 2, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: August 2, 2022

US FDA News: North American Diagnostics Recalls Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits That Are Not Authorized, Cleared, or Approved by the FDA

North American Diagnostics Recalls Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits because they are not authorized, cleared, or approved by the FDA.
Read more: North American Diagnostics Recalls Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits That Are Not Authorized, Cleared, or Approved by the FDA