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NEWS & BLOGS
Blog: Blog2
Provision Consulting Group
Jan 10, 20221 min read
FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine to Five MonthsShareTweetLinked
January 07, 2022, The U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine to...
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Provision Consulting Group
Jan 3, 20225 min read
FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/do-i-qualify-covid-19-vaccine-booster-and-which...
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Provision Consulting Group
Dec 30, 20213 min read
Two New Over-the-Counter At-Home COVID-19 Tests Brought to U.S Market by Biden-Harris Administration
FDA Authorizes Roche and Siemens At-Home Tests, Which Went Through New Biden Administration Accelerated Review Program; Will Bring Tens...
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Provision Consulting Group
Dec 27, 20211 min read
FDA Urges Manufacturers to Develop Solutions for iPLEDGE REMS Website
https://www.facebook.com/FDA FDA is aware that patients, prescribers, and pharmacies are experiencing difficulties with...
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Provision Consulting Group
Dec 21, 20213 min read
FDA approves drug to treat, help prevent types of blood clots in certain pediatric populations
Action FDA has approved Xarelto (rivaroxaban) as tablets and an oral suspension to treat venous thromboembolism (VTE), or blood clots...
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Provision Consulting Group
Dec 20, 20212 min read
FDA approves drug to treat sickle cell disease in patients aged 4 up to 11 years
Action FDA has granted accelerated approval for Oxbryta (voxelotor) tablets to treat sickle cell disease in pediatric patients aged four...
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Provision Consulting Group
Dec 16, 20212 min read
FDA approves first drug to decrease urine protein in IgA nephropathy, a rare kidney disease
Action FDA has granted accelerated approval for Tarpeyo (budesonide) delayed release capsules to reduce proteinuria (increased protein...
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Provision Consulting Group
Dec 15, 20213 min read
FDA Approves First Drug to Prevent Graft Versus Host Disease
Today, the U.S. Food and Drug Administration approved Orencia (abatacept) for the prophylaxis (prevention) of acute graft versus host...
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Provision Consulting Group
Dec 9, 20214 min read
FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-Olds
Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-Olds Today, the U.S....
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Provision Consulting Group
Dec 9, 20214 min read
FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19
Coronavirus (COVID-19) Update: FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain...
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Provision Consulting Group
Dec 6, 20213 min read
FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention
FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention of COVID-19 to Younger Pediatric...
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Provision Consulting Group
Nov 29, 20212 min read
FDA Approves New Imaging Drug to Help Identify Ovarian Cancer Lesions
The U.S. Food and Drug Administration today approved Cytalux (pafolacianine), an imaging drug intended to assist surgeons in identifying...
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Provision Consulting Group
Nov 24, 20212 min read
FDA Approves First Treatment for Post- Transplant Infection that is Resistant to Other Drugs
The U.S. Food and Drug Administration approved Livtencity (maribavir) as the first drug for treating adults and pediatric patients (12...
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Provision Consulting Group
Nov 22, 20212 min read
FDA Approves First Drug to Improve Growth in Children with Most Common Form of Dwarfism
The U.S. Food and Drug Administration approved Voxzogo (vosoritide) injection to improve growth in children five years of age and older...
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Provision Consulting Group
Nov 19, 20214 min read
FDA Expands Eligibility for COVID-19 Vaccine Boosters
Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech...
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Provision Consulting Group
Nov 5, 20212 min read
FDA Provides New Draft Guidance on Premarket Submissions for Device Software Functions
The following quote is attributed to Bakul Patel, director of FDA’s Digital Health Center of Excellence in the Center for Devices and...
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Provision Consulting Group
Nov 2, 20217 min read
FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury
Immediately and thoroughly rinse eyes with gently running water if this occurs What safety concern is FDA announcing? The U.S. Food and...
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Provision Consulting Group
Oct 29, 20215 min read
FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years
Today, the U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of...
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Provision Consulting Group
Oct 27, 20212 min read
FDA Continues Efforts to Detect and Assess Asbestos in Cosmetics for Consumers
The following quote is attributed to Linda Katz, director of the FDA's Office of Cosmetics and Colors: “The FDA remains dedicated to...
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Provision Consulting Group
Oct 21, 20215 min read
FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines
The U.S. Food and Drug Administration took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. The...
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