US FDA News: FDA Roundup: April 29, 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: April 29, 2022

US FDA News: Coronavirus (COVID-19) Update: FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID- 19 Vaccines

The FDA plans to hold virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) in anticipation of potential submissions of emergency use authorization (EUA) requests in the coming months that have been publicly announced by COVID-19 vaccine manufacturers.
Read more: Coronavirus (COVID-19) Update: FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID- 19 Vaccines

US FDA News: La FDA propone normas que prohíben los cigarrillos mentolados y puros saborizados para prevenir la iniciación al tabaquismo en adolescentes y reducir significativamente la morbilidad y mortalidad relacionadas con el uso del tabaco

La FDA ha propuesto normas para productos de tabaco que prohíben el mentol en los cigarrillos y todos los sabores en los puros.
Read more: La FDA propone normas que prohíben los cigarrillos mentolados y puros saborizados para prevenir la iniciación al tabaquismo en adolescentes y reducir significativamente la morbilidad y mortalidad relacionadas con el uso del tabaco

US FDA News: Stop New Implants of the Medtronic HVAD System – Letter to Health Care Providers

Medtronic has stopped the sale and distribution of HVAD because the internal pump may delay or fail to restart.
Read more: Stop New Implants of the Medtronic HVAD System – Letter to Health Care Providers

US FDA News: Potential for Internal Pump Malfunction in the Medtronic HVAD System – Letter to Health Care Providers

The FDA is issuing this letter to ensure you are aware of this defect and the recommended actions to take to manage the care of patients currently implanted with a Medtronic HVAD system.
Read more: Potential for Internal Pump Malfunction in the Medtronic HVAD System – Letter to Health Care Providers

US FDA News: Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Which May Have Been Distributed to Unauthorized, Non-CLIA-Certified Users

COVID-19 Ag Rapid Tests are being recalled because they may have been distributed to unauthorized, non-CLIA-certified users.
Read more: Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Which May Have Been Distributed to Unauthorized, Non-CLIA-Certified Users

US FDA News: FDA Proposes Rules Prohibiting Menthol Cigarettes and Flavored Cigars to Prevent Youth Initiation, Significantly Reduce Tobacco-Related Disease and Death

FDA proposed product standards to prohibit menthol in cigarettes and all flavors in cigars.
Read more: FDA Proposes Rules Prohibiting Menthol Cigarettes and Flavored Cigars to Prevent Youth Initiation, Significantly Reduce Tobacco-Related Disease and Death

US FDA News: FDA Takes Steps to Limit Lead in Juice to Further Reduce Exposure to Toxic Elements in Foods

FDA Takes Steps to Limit Lead in Juice to Further Reduce Exposure to Toxic Elements in Foods
Read more: FDA Takes Steps to Limit Lead in Juice to Further Reduce Exposure to Toxic Elements in Foods

US FDA News: Potential Risk of Airway Obstruction When Using Certain Electromyogram Endotracheal Tubes – Letter to Health Care Providers

The FDA has received reports of airway obstruction and ventilation failure for certain EMG endotracheal tubes.
Read more: Potential Risk of Airway Obstruction When Using Certain Electromyogram Endotracheal Tubes – Letter to Health Care Providers

US FDA News: FDA Roundup: April 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: April 26, 2022

US FDA News: Medtronic Recalls Harmony Delivery Catheter, Part of Transcatheter Pulmonary Valve (TPV) System, for Risk of Capsule Break During Use

The capsule at the end of the delivery catheter used to place Harmony’s pulmonary valve may come loose during placement due to a bond break.
Read more: Medtronic Recalls Harmony Delivery Catheter, Part of Transcatheter Pulmonary Valve (TPV) System, for Risk of Capsule Break During Use

US FDA News: Coronavirus (COVID-19) Update: FDA Approves First COVID-19 Treatment for Young Children

Today, the FDA approved the first COVID-19 treatment for children less than 12 years of age.
Read more: Coronavirus (COVID-19) Update: FDA Approves First COVID-19 Treatment for Young Children

US FDA News: Pfizer Voluntary Nationwide Recall of Lots of ACCUPRIL® (Quinapril HCl) Due to N-Nitroso-Quinapril Content

Pfizer is voluntarily recalling five (5) lots of Accupril (Quinapril HCl) tablets distributed by Pfizer to the patient (consumer/user) level due to the presence of a nitrosamine, Nnitroso-quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level.

Read more: Pfizer Voluntary Nationwide Recall of Lots of ACCUPRIL® (Quinapril HCl) Due to N-Nitroso-Quinapril Content

US FDA News: FDA Roundup: April 22, 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: April 22, 2022

US FDA News: FDA Considers New Approach to Improve Safe Disposal of Prescription Opioid Analgesics, Decrease Unnecessary Exposure to Unused Medication

The U.S Food and Drug Administration established a public docket to consider adding a mail-back envelope requirement to the Opioid Analgesic Risk Evaluation and Mitigation Strategy to require that all opioid analgesics, including immediate-release, extended-release, and long-acting formulations, use
Read more: FDA Considers New Approach to Improve Safe Disposal of Prescription Opioid Analgesics, Decrease Unnecessary Exposure to Unused Medication

US FDA News: FDA Roundup: April 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: April 19, 2022

US FDA News: FDA Warns of Risks Associated with Non-Invasive Prenatal Screening Tests

Today, the FDA is warning the public of the risk of false results, inappropriate use and inappropriate interpretation of results with non-invasive prenatal screening tests, also called cell-free DNA tests or non-invasive prenatal tests.
Read more: FDA Warns of Risks Associated with Non-Invasive Prenatal Screening Tests

US FDA News: Genetic Non-Invasive Prenatal Screening Tests May Have False Results: FDA Safety Communication

Pregnant patients should discuss test results with a health care provider before making any decisions about their pregnancy
Read more: Genetic Non-Invasive Prenatal Screening Tests May Have False Results: FDA Safety Communication

US FDA News: FDA Takes New Steps Regarding Evaluating Public Health Importance of Additional Food Allergens

FDA Takes New Steps Regarding Evaluating Public Health Importance of Additional Food Allergens
Read more: FDA Takes New Steps Regarding Evaluating Public Health Importance of Additional Food Allergens

US FDA News: FDA Roundup: April 15, 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: April 15, 2022

US FDA News: Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples

Today, the FDA issued an emergency use authorization for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection.
Read more: Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples

US FDA News: FDA Issues Final Guidance on Animal Drug Compounding from Bulk Drug Substances

FDA issued a final guidance that will help protect animal health by addressing need for access to certain compounded animal drugs.
Read more: FDA Issues Final Guidance on Animal Drug Compounding from Bulk Drug Substances

US FDA News: FDA Takes Important Steps to Increase Racial and Ethnic Diversity in Clinical Trials

The FDA issued a new draft guidance to industry for developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials – expanding on the agency’s previous guidances for industry to improve clinical trial diversity.
Read more: FDA Takes Important Steps to Increase Racial and Ethnic Diversity in Clinical Trials

US FDA News: Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), Due to the Potential for a Missing Label in the Batch

Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its Insulin Glargine (Insulin glargineyfgn) Injection, 100 units/mL (U-100), which is packaged in a 10 mL vial that is inside a carton. This product is not the branded Semglee vial but the unbranded Insulin Glargine
Read more: Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), Due to the Potential for a Missing Label in the Batch

US FDA News: FDA Roundup: April 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: April 12, 2022

US FDA News: FDA and DEA Warn Online Pharmacies Illegally Selling Adderall to Consumers

The U.S. Food and Drug Administration and the U.S. Drug Enforcement Administration have issued joint warning letters to two online sellers of illegal versions of Schedule II stimulants (including amphetamines marketed illicitly as Adderall) that are not FDA approved.
Read more: FDA and DEA Warn Online Pharmacies Illegally Selling Adderall to Consumers

US FDA News: Intended Use of Imaging Software for Intracranial Large Vessel Occlusion - Letter to Health Care Providers

The U.S. Food and Drug Administration (FDA) wants to increase awareness about the intended use of imaging software for intracranial large vessel occlusion or LVO.
Read more: Intended Use of Imaging Software for Intracranial Large Vessel Occlusion - Letter to Health Care Providers

US FDA News: FDA Roundup: April 8, 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: April 8, 2022

US FDA News: Joint Statement from CMS Administrator Chiquita Brooks-LaSure and FDA Commissioner Robert M. Califf, M.D., on Ensuring Access to Safe and Effective Treatments

Joint Statement from CMS Administrator Chiquita Brooks-LaSure and FDA Commissioner Robert M. Califf, M.D., on Ensuring Access to Safe and Effective Treatments.
Read more: Joint Statement from CMS Administrator Chiquita Brooks-LaSure and FDA Commissioner Robert M. Califf, M.D., on Ensuring Access to Safe and Effective Treatments

US FDA News: FDA Roundup: April 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: April 5, 2022

US FDA News: Recommendations About the Use of Dental Amalgam in Certain High-Risk Populations: FDA Safety Communication

The FDA is providing recommendations for certain high-risk populations may be more vulnerable to potential adverse health effects of mercury exposure from dental amalgam.
Read more: Recommendations About the Use of Dental Amalgam in Certain High-Risk Populations: FDA Safety Communication

US FDA News: The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication

FDA is sharing recommendations and updates to help improve duodenoscope reprocessing.
Read more: The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication

US FDA News: Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication

Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication
Read more: Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication

US FDA News: Infections Associated with Reprocessed Urological Endoscopes - Letter to Health Care Providers

The FDA wants to raise awareness among health care providers about the risk of infections associated with reprocessed urological endoscopes.
Read more: Infections Associated with Reprocessed Urological Endoscopes - Letter to Health Care Providers

US FDA News: UPDATE: Change in Reprocessing Methods with Certain Karl Storz Urological Endoscopes – Letter to Health Care Providers

Do not use high-level disinfection methods for reprocessing affected urological endoscopes from Karl Storz.
Read more: UPDATE: Change in Reprocessing Methods with Certain Karl Storz Urological Endoscopes – Letter to Health Care Providers

US FDA News: Best Brand Consumers Products, Inc. Issues Voluntary Recall of Mickey Mouse Hand Sanitizer Ethyl Alcohol 68% Due to Presence of Methanol and the Mandalorian Hand Sanitizer Ethyl Alcohol 68% Due to the Presence of Benzene

Best Brands Consumer Products, Inc. is voluntarily recalling two (2) finished product lots of The Mandalorian Hand Sanitizer Ethyl Alcohol 68%, available in green and blue formulations and Mickey Mouse Hand Sanitizer Ethyl Alcohol 68% blue formulation to the consumer level.
Read more: Best Brand Consumers Products, Inc. Issues Voluntary Recall of Mickey Mouse Hand Sanitizer Ethyl Alcohol 68% Due to Presence of Methanol and the Mandalorian Hand Sanitizer Ethyl Alcohol 68% Due to the Presence of Benzene

US FDA News: F&S Medical Supply, DBA Pink Toyz Issues Voluntary Nationwide Recall of Pink Pussycat Capsules Due to the Presence of Undeclared Sildenafil

Chatsworth, California, F&S Medical Supply, dba Pink Toyz is voluntarily recalling one lot of Pink Pussycat 3000 mg capsules to the consumer level. FDA analysis has found the product Pink Pussycat to be tainted with sildenafil, an ingredient known as a phosphodiesterase (PDE-5) inhibitor found in an
Read more: F&S Medical Supply, DBA Pink Toyz Issues Voluntary Nationwide Recall of Pink Pussycat Capsules Due to the Presence of Undeclared Sildenafil

US FDA News: FDA Roundup: April 1, 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: April 1, 2022