US FDA News: FDA Roundup: May 31, 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: May 31, 2022

US FDA News: FDA Roundup: May 27, 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: May 27, 2022

US FDA News: FDA Efforts to Result in Millions of Additional Bottles of Infant Formula to Further Increase U.S. Supply

The FDA is providing an update on additional steps it has taken that will lead to more infant formula on U.S. store shelves in the coming weeks and months.
Read more: FDA Efforts to Result in Millions of Additional Bottles of Infant Formula to Further Increase U.S. Supply

US FDA News: ArjoHuntleigh Polska Recalls Sara Plus Floor Lift for Risk of Smoke or Fire When Lift Is Used with Depleted Battery

The Arjo Sara Plus is an active floor lift. When it is used with a depleted battery, the device may smoke or catch on fire.
Read more: ArjoHuntleigh Polska Recalls Sara Plus Floor Lift for Risk of Smoke or Fire When Lift Is Used with Depleted Battery

US FDA News: FDA Flexibilities, Collaboration to Yield Millions of Bottles of Specialized Medical Infant Formula in Coming Months to Increase U.S. Supply

The FDA is providing an update on steps it has taken that will lead to millions of bottles of specialized medical infant formula to help address immediate needs for infants with certain allergies or critical health conditions.
Read more: FDA Flexibilities, Collaboration to Yield Millions of Bottles of Specialized Medical Infant Formula in Coming Months to Increase U.S. Supply

US FDA News: Abbott Medical Recalls Dragonfly OpStar Imaging Catheter for Potential Loose Catheter Marker Band That May Cause Patient Harm

The Dragonfly OpStar imaging catheter is used to image coronary arteries. A marker band on it may become loose during use, which may cause harm to the patient.
Read more: Abbott Medical Recalls Dragonfly OpStar Imaging Catheter for Potential Loose Catheter Marker Band That May Cause Patient Harm

US FDA News: Urgent Voluntary Recall: CorneaGen Cornea/ Cornea Patch Grafts; CorneaGen is voluntarily recalling Corneal Patch Grafts bearing the following product numbers: W419221004861104; W419221004861105; W419221004861106; W419221004861103

On January 5, 2022, CorneaGen discovered that Cornea Patch Grafts were obtained from a donor who tested reactive for HIV-1/HIV-2 Plus O antibody and were shipped prior to being medically cleared.
Read more: Urgent Voluntary Recall: CorneaGen Cornea/ Cornea Patch Grafts; CorneaGen is voluntarily recalling Corneal Patch Grafts bearing the following product numbers: W419221004861104; W419221004861105; W419221004861106; W419221004861103

US FDA News: FDA Flexibilities to Yield Millions of Cans of Additional Infant Formula in Coming Months to Increase Supply Available to U.S. Consumers

FDA is providing an update on steps it has taken that will lead to millions of cans of additional infant and specialty formula being available to U.S. consumers.
Read more: FDA Flexibilities to Yield Millions of Cans of Additional Infant Formula in Coming Months to Increase Supply Available to U.S. Consumers

US FDA News: FDA Roundup: May 24, 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: May 24, 2022

US FDA News: FDA Approves First Treatment for Eosinophilic Esophagitis, a Chronic Immune Disorder

The FDA approved the first treatment for eosinophilic esophagitis, a chronic immune disorder, in adults and pediatric patients (12 years and older weighing at least 40 kilograms, which is about 88 pounds).
Read more: FDA Approves First Treatment for Eosinophilic Esophagitis, a Chronic Immune Disorder

US FDA News: FDA Roundup: May 20, 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: May 20, 2022

US FDA News: Urgent Voluntary Recall: CorneaGen Sclera / Scleral Patch Grafts; CorneaGen is voluntarily recalling the entire lot of Scleral Patch Grafts obtained from (Lot Number) W419221008338

CorneaGen is voluntarily recalling the entire lot of Scleral Patch Grafts obtained from (Lot Number) W419221008338
Read more: Urgent Voluntary Recall: CorneaGen Sclera / Scleral Patch Grafts; CorneaGen is voluntarily recalling the entire lot of Scleral Patch Grafts obtained from (Lot Number) W419221008338

US FDA News: 2022 Biologics Recalls

Listing of the 2022 Biologics Recalls
Read more: 2022 Biologics 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 Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain

FDA is issuing a draft guidance, Risk Management Plans to Mitigate the Potential for Drug Shortages, intended to help with the development, maintenance and implementation of risk management plans.
Read more: FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain

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: New FDA Draft Guidance Aims to Increase Safety Information About Dietary Supplement Marketplace

The FDA announced the availability of a draft guidance aimed at increasing the amount of safety information the agency has about the dietary supplement marketplace by providing the industry an opportunity to submit late new dietary ingredient (NDI) notifications.
Read more: New FDA Draft Guidance Aims to Increase Safety Information About Dietary Supplement Marketplace

US FDA News: FDA Roundup: May 17, 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: May 17, 2022

US FDA News: Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years

The FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 Vaccine
Read more: Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years

US FDA News: FDA Encourages Importation of Safe Infant Formula and Other Flexibilities to Further Increase Availability

FDA announced guidance outlining increased flexibilities on importation of certain infant formula products to further increase the availability across the country while protecting the health of infants.
Read more: FDA Encourages Importation of Safe Infant Formula and Other Flexibilities to Further Increase Availability

US FDA News: FDA Provides New Updates on Activities to Mitigate Infant Formula Supply Challenges, Abbott Nutrition Agrees to Take Corrective Actions at Facility to Produce Safe Infant Formula

Under the proposed consent decree, Abbott has agreed to take corrective actions following an FDA inspection of its Sturgis, Michigan, facility.
Read more: FDA Provides New Updates on Activities to Mitigate Infant Formula Supply Challenges, Abbott Nutrition Agrees to Take Corrective Actions at Facility to Produce Safe Infant Formula

US FDA News: Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test Available without a Prescription That Also Detects Flu and RSV

Today, FDA authorized the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test, the first direct-to-consumer (non-prescription) multi-analyte COVID-19 test authorized by FDA.
Read more: Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test Available without a Prescription That Also Detects Flu and RSV

US FDA News: Woodside Acquisitions Inc. Recalls Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) That Are Not Authorized, Cleared, or Approved by the FDA

Woodside Acquisitions Inc. recalls COVID-19 Rapid Test Kits because they are not authorized, cleared, or approved by the FDA.
Read more: Woodside Acquisitions Inc. Recalls Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) That Are Not Authorized, Cleared, or Approved by the FDA

US FDA News: FDA Roundup: May 13, 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: May 13, 2022

US FDA News: Avanos Medical Recalls Cortrak*2 Enteral Access System for Risk of Misplaced Enteral Tubes Could Cause Patient Harm

Avanos Medical CORTRAK*2 Enteral Access System is being recalled because misplaced enteral tubes may cause patient harm.
Read more: Avanos Medical Recalls Cortrak*2 Enteral Access System for Risk of Misplaced Enteral Tubes Could Cause Patient Harm

US FDA News: FDA Approves Novel, Dual-Targeted Treatment for Type 2 Diabetes

The FDA approved a new treatment to improve blood sugar control in adults with type 2 diabetes, as an addition to diet and exercise.
Read more: FDA Approves Novel, Dual-Targeted Treatment for Type 2 Diabetes

US FDA News: FDA Roundup: May 10, 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: May 10, 2022

US FDA News: FDA Takes Important Steps to Improve Supply of Infant and Specialty Formula Products

The FDA is providing an update on its work to increase the availability of infant and specialty formula products.
Read more: FDA Takes Important Steps to Improve Supply of Infant and Specialty Formula Products

US FDA News: SML Distribution LLC Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA

SML Distribution Recalls Unauthorized COVID-19 Direct Antigen Rapid Tests because they are not authorized, cleared, or approved by the FDA.
Read more: SML Distribution LLC Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA

US FDA News: Do Not Use Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test: FDA Safety Communication

The FDA is warning people not to use the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Tests. The test’s performance has not been adequately established.
Read more: Do Not Use Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test: FDA Safety Communication

US FDA News: Mesa Biotech, Inc., Recalls Certain Accula SARS-CoV-2 Tests for Risk of False Positives Caused by Contamination

Mesa BioTech’s Accula SARS-CoV-2 Tests are being recalled because facility contamination may cause them to give false positive results.
Read more: Mesa Biotech, Inc., Recalls Certain Accula SARS-CoV-2 Tests for Risk of False Positives Caused by Contamination

US FDA News: FDA Roundup: May 6, 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: May 6, 2022

US FDA News: Potential Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis Machines Manufactured by Fresenius Medical Care – Letter to Health Care Providers

The FDA is evaluating the potential risk of exposure to toxic compounds when using certain Fresenius Medical Care hemodialysis machines
Read more: Potential Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis Machines Manufactured by Fresenius Medical Care – Letter to Health Care Providers

US FDA News: Coronavirus (COVID-19) Update: FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals

The FDA has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 older for whom other available COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 and older who elect to receive it because they would otherwise not receive a COVID-19 vaccine.
Read more: Coronavirus (COVID-19) Update: FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals

US FDA News: FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer’s Disease

FDA today permitted marketing for the first in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer’s disease.
Read more: FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer’s Disease

US FDA News: FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products

The FDA issued warning letters to five companies for selling products labeled as containing delta-8 THC in ways that violate the FD&C Act. This action is the first time the FDA has issued warning letters for products containing delta-8 THC.
Read more: FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products

US FDA News: FDA Roundup: May 3, 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: May 3, 2022

US FDA News: Philips Respironics Issues Voluntary Recall Notification/Field Safety Notice* for the V60 Ventilator Product Family

Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that its subsidiary Philips Respironics is notifying customers of its V60/V60 Plus and V680 ventilators about a potential issue with the electrical circuit in these ventilators that controls the 35V power sup
Read more: Philips Respironics Issues Voluntary Recall Notification/Field Safety Notice* for the V60 Ventilator Product Family

US FDA News: Fagron Inc. Issues Voluntary Nationwide Recall of SyrSpend SF Cherry Due to Microbial Contamination

St. Paul, Minnesota, Fagron Inc. (“Fagron”) is voluntarily recalling two lots of SyrSpend SF Cherry to the hospital, pharmacy, and distributor level out of an abundance of caution. The affected lots are potentially contaminated with Burkholderia gladioli. Burkholderia gladioli is an opportunistic pa
Read more: Fagron Inc. Issues Voluntary Nationwide Recall of SyrSpend SF Cherry Due to Microbial Contamination