top of page
.png){kind=logo}
NEWS & BLOGS
Blog: Blog2
FDA Safety Warning, Stop Using Empowered Diagnostics COVID-19 Tests
Date Issued: January 28, 2022 The U.S. Food and Drug Administration (FDA) is warning people to stop using the Empowered Diagnostics...
Provision Consulting Group
Jan 29, 20224 min read
FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant
The following is attributed to Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research January 24, 2022,...
Provision Consulting Group
Jan 24, 20223 min read
FDA Takes Actions to Expand Use of Treatment for Outpatients with Mild-to-Moderate COVID-19
January 21,2022, The U.S. Food and Drug Administration took two actions to expand the use of the antiviral drug Veklury (remdesivir) to...
Provision Consulting Group
Jan 24, 20223 min read
FDA warns about dental problems with buprenorphine medicines
FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain Benefits for...
Provision Consulting Group
Jan 13, 20224 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...
Provision Consulting Group
Jan 10, 20221 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...
Provision Consulting Group
Jan 3, 20225 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...
Provision Consulting Group
Dec 30, 20213 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...
Provision Consulting Group
Dec 27, 20211 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...
Provision Consulting Group
Dec 21, 20213 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...
Provision Consulting Group
Dec 20, 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...
Provision Consulting Group
Dec 16, 20212 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...
Provision Consulting Group
Dec 15, 20213 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....
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...
Provision Consulting Group
Dec 9, 20214 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...
Provision Consulting Group
Dec 6, 20213 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...
Provision Consulting Group
Nov 29, 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...
Provision Consulting Group
Nov 24, 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...
Provision Consulting Group
Nov 22, 20212 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...
Provision Consulting Group
Nov 19, 20214 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...
Provision Consulting Group
Nov 5, 20212 min read
bottom of page