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NEWS & BLOGS
Blog: Blog2
FDA approves alpelisib for PIK3CA-related overgrowth spectrum
Apr 06 2022 On April 5, 2022, the Food and Drug Administration granted accelerated approval to alpelisib (Vijoice, Novartis...
Provision Consulting Group
Apr 8, 20222 min read
FDA updates Sotrovimab emergency use authorization
Apr 05 2022 Update [4/5/2022] Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion...
Provision Consulting Group
Apr 5, 20222 min read
FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines
Mar 29 2022 The U.S. Food and Drug Administration(FDA) authorized a second booster dose of either the Pfizer-BioNTech or the Moderna...
Provision Consulting Group
Mar 29, 20224 min read
FDA Issues Guidance on Certain Ophthalmic Products: Policy for Compliance With 21 CFR Part 4
Mar 28 2022 The U.S. Food and Drug Administration(FDA) issued the guidance for industry, Certain Ophthalmic Products: Policy Regarding...
Provision Consulting Group
Mar 28, 20222 min read
FDA updates Sotrovimab emergency use authorization
Mar 25 2022 On March 25, 2022, FDA limits use of Sotrovimab to treat COVID-19 in some U.S. regions due to the BA.2 Omicron sub-variant....
Provision Consulting Group
Mar 25, 20222 min read
FDA, Additional Procedural Notice on Consumer Research on “Healthy” Symbol
Mar 25 2022 FDA Issues Additional Procedural Notice on Consumer Research on “Healthy” Symbol. The U.S. Food and Drug Administration is...
Provision Consulting Group
Mar 25, 20221 min read
FDA approves Pluvicto for metastatic castration-resistant prostate cancer
Mar 24 2022 On March 23, 2022, the Food and Drug Administration approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, Advanced...
Provision Consulting Group
Mar 24, 20222 min read
FDA Approves First Generic of Symbicort to Treat Asthma and COPD
Mar 15 2022 On March 15 2022, The U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol...
Provision Consulting Group
Mar 15, 20222 min read
FDA, FY 2022 OTC Monograph Drug User Fee(OMUFA)
Mar 14 2022 On March 14, 2022, FDA announced the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2022. OTC...
Provision Consulting Group
Mar 14, 20221 min read
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...
Provision Consulting Group
Mar 8, 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...
Provision Consulting Group
Mar 7, 20223 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...
Provision Consulting Group
Mar 7, 20221 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...
Provision Consulting Group
Mar 1, 20222 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...
Provision Consulting Group
Feb 28, 20221 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...
Provision Consulting Group
Feb 28, 20223 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...
Provision Consulting Group
Feb 24, 20222 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...
Provision Consulting Group
Feb 22, 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%...
Provision Consulting Group
Feb 2, 20223 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...
Provision Consulting Group
Feb 1, 20222 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...
Provision Consulting Group
Jan 31, 20224 min read
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