DeECO

How Gene Therapy Can Cure or Treat Diseases

By DeECO / July 28, 2022 / Comments Off on How Gene Therapy Can Cure or Treat Diseases

Original Post The genes in your body’s cells play a key role in your health. Indeed, a defective gene or genes can make you sick. Recognizing this, scientists have worked for decades on ways to modify genes or replace faulty genes with healthy ones to treat, cure, or prevent a disease or medical condition. This…

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Vi-Jon, LLC Expands Voluntary Nationwide Recall of All Flavors and Lots Within Expiry of Magnesium Citrate Saline Laxative Oral Solution Due to Microbial Contamination

By DeECO / July 27, 2022 / Comments Off on Vi-Jon, LLC Expands Voluntary Nationwide Recall of All Flavors and Lots Within Expiry of Magnesium Citrate Saline Laxative Oral Solution Due to Microbial Contamination

Original Post Summary Company Announcement Date: July 25, 2022 FDA Publish Date: July 26, 2022 Product Type: Drugs  Reason for Announcement: Potential Gluconacetobacter liquefaciens contamination Company Name: Vi-Jon, LLC Brand Name: Multiple Brands Product Description: Magnesium Citrate Saline Laxative Oral Solution Company Announcement FOR IMMEDIATE RELEASE – July 25, 2022 – Smyrna, TN, Vi-Jon, LLC is expanding its voluntary…

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Voluntary Recall of Certain Over-the-Counter Products

By DeECO / July 26, 2022 / Comments Off on Voluntary Recall of Certain Over-the-Counter Products

Original Post Summary Company Announcement Date: July 21, 2022 FDA Publish Date: July 21, 2022 Product Type: Drugs  Reason for Announcement: Products stored outside of temperature requirements Company Name: Family Dollar Brand Name: Multiple brands Product Description: Multiple OTC Medical Products Company Announcement Family Dollar is initiating a voluntary retail level product recall of certain…

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SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests

By DeECO / July 25, 2022 / Comments Off on SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests

Original Post The SARS-CoV-2 virus has mutated over time, resulting in genetic variation in the population of circulating viral strains, also called lineages. This genetic variation may impact the virus’s properties such as transmission (for example, it may spread more easily) or the severity of symptoms on infected individuals (for example, it may cause more…

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Do Not Use Ultraviolet (UV) Wands That Give Off Unsafe Levels of Radiation: FDA Safety Communication

By DeECO / July 21, 2022 / Comments Off on Do Not Use Ultraviolet (UV) Wands That Give Off Unsafe Levels of Radiation: FDA Safety Communication

Original Post Date Issued:  July 20, 2022 The U.S. Food and Drug Administration (FDA) is warning consumers about the potential risk of injury associated with the use of certain brands of ultraviolet (UV) wands. Do not use these UV wands for disinfection because they may expose the user or any nearby person to unsafe levels…

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For Monkeypox Testing, Use Lesion Swab Samples to Avoid False Results: FDA Safety Communication

By DeECO / July 19, 2022 / Comments Off on For Monkeypox Testing, Use Lesion Swab Samples to Avoid False Results: FDA Safety Communication

Original Post Date Issued: July 15, 2022 The U.S. Food and Drug Administration (FDA) is advising people to use swab samples taken directly from a lesion (rash or growth) when testing for the monkeypox virus. The FDA is not aware of clinical data supporting the use of other sample types, such as blood or saliva,…

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Coronavirus (COVID-19) Update: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted

By DeECO / July 18, 2022 / Comments Off on Coronavirus (COVID-19) Update: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted

Original Post For Immediate Release: July 13, 2022 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.  “Authorizing an additional COVID-19 vaccine expands…

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FDA Provides Educational Resources for Parents and Caregivers to Support Confidence for Imported Infant Formula Products

By DeECO / July 14, 2022 / Comments Off on FDA Provides Educational Resources for Parents and Caregivers to Support Confidence for Imported Infant Formula Products

Original Post For Immediate Release:July 14, 2022 Today, the U.S. Food and Drug Administration announced the availability of educational resources for parents and caregivers with questions about using the hundreds of millions of bottles worth of imported infant formula headed to the U.S.  “Parents and caregivers should have confidence that our collective work with federal partners, manufacturers…

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FDA Infant Formula Update: July 8, 2022

By DeECO / July 11, 2022 / Comments Off on FDA Infant Formula Update: July 8, 2022

Original Post For Immediate Release: July 08, 2022 Today, the U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S. under the agency’s recent increased flexibilities. Company (Product Origin): Care A2+ (Australia) Product(s): Care A2+ 0-12 Months Infant Formula Type of Formula: General…

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Coronavirus (COVID-19) Update: FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations

By DeECO / July 7, 2022 / Comments Off on Coronavirus (COVID-19) Update: FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations

Original Post New Prescribing Authority Could Improve Access for Some Patients at High Risk for Severe COVID-19 For Immediate Release: July 06, 2022 Today, the U.S. Food and Drug Administration revised the Emergency Use Authorization(EUA) for Paxlovid (nirmatrelvir and ritonavir), to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate…

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