FDA Clinical Trial Guidances for Advancing Development of Cancer Treatments
Mar 08 2022 March 01 2022, the U.S. Food and Drug Administration issued three final guidances to industry regarding cancer clinical...
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NEWS & BLOGS
Blog: Blog2
Provision Consulting Group
Mar 7, 20223 min read
FDA, CDER's Drug Approvals and Programming to Speed Therapeutic Development
Mar 07 2022 FDA I Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research A rare disease is any disease that...
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Provision Consulting Group
Mar 7, 20221 min read
OTC Monograph Reform: Overview of Draft Guidance for Formal Meetings
Mar 07 2022 Date: March 29, 2022 Time: 2:00 PM - 3:00 PM ET ABOUT THIS WEBINAR During this webinar, FDA will provide an overview of the...
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Provision Consulting Group
Mar 1, 20222 min read
FDA approves drug for adults with rare form of bone marrow disorder
Mar 01 2022 FDA has granted accelerated approval for Vonjo (pacritinib) capsules to treat adults who have a rare form of a bone marrow...
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Provision Consulting Group
Feb 28, 20221 min read
FDA updates Sotrovimab emergency use authorization
Feb 28 2022 [2/25/2022] The U.S. Food and Drug Administration is continually monitoring how authorized and approved treatments for...
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Provision Consulting Group
Feb 28, 20223 min read
FDA authorizes revisions to Evusheld dosing
Feb 28 2022 [2/24/2022] The U.S. Food and Drug Administration has revised the emergency use authorization for Evusheld (tixagevimab...
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Provision Consulting Group
Feb 24, 20222 min read
FDA Approves Treatment for Wider Range of Patients with Heart Failure
Feb 24 2022 Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death...
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Provision Consulting Group
Feb 22, 20223 min read
FDA Alerts the Public to Potentially Contaminated Products from Family Dollar Stores in Six States
Feb 22 2022 Pictured are circulars at a Family Dollar store in Chicago on March 3, 2020.Daniel Acker/Bloomberg/Getty Images Today, the...
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Provision Consulting Group
Feb 2, 20223 min read
FDA Approves First Generic of Restasis
Feb 02 2022 The U.S. Food and Drug Administration has approved the first generic of Restasis (cyclosporine ophthalmic emulsion) 0.05%...
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Provision Consulting Group
Feb 1, 20222 min read
FDA, Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age
FDA Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4...
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Provision Consulting Group
Jan 31, 20224 min read
FDA Takes Key Action by Approving Second COVID-19 Vaccine
Jan 31 2022 Today, the U.S. Food and Drug Administration approved a second COVID-19 vaccine. The vaccine has been known as the Moderna...
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Provision Consulting Group
Jan 29, 20224 min read
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...
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Provision Consulting Group
Jan 24, 20223 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,...
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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...
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Provision Consulting Group
Jan 13, 20224 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...
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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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