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NEWS & BLOGS
Blog: Blog2
FDA Regulation of Product Label with Expiration Dates
Jun 06, 2022 The United States Food and Drug Administration develops and administers regulations under authority granted by laws passed...
Provision Consulting Group
Jun 6, 20223 min read
Quality System FDA Regulation for Medical Devices
Jun 03 2022 Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable...
Provision Consulting Group
Jun 3, 20224 min read
Design Control for Home Use Medical Device Manufacturers
Jun 01 2022 For the manufacturers which Develop a new home-use device, we provide this guidance, and it applies to both prescription and...
Provision Consulting Group
Jun 1, 20223 min read
FDA approves azacitidine for newly diagnosed juvenile myelomonocytic leukemia
May 25 2022 The Food and Drug Administration approved azacitidine (Vidaza, Celgene Corp.) for pediatric patients with newly diagnosed...
Provision Consulting Group
May 25, 20222 min read
FDA Regulatory Design Control Requirements for Medical Device Startups
May 23 2022 The U.S. Food and Drug Administration (FDA) recognizes these risks and strictly regulates design control requirements to...
Provision Consulting Group
May 23, 20222 min read
Does your product require FDA Approval?
May 13 2022 Most of the products on the market show a mark or ads that they have been approved by the FDA. And many companies say their...
Provision Consulting Group
May 13, 20225 min read
FDA approves OCS(Organ Care System) Heart System new medical technology
May 11 2022 The U.S. Food and Drug Administration(FDA) granted PMA(Premarket Approval) for OCS Heart System its donor hearts for...
Provision Consulting Group
May 11, 20222 min read
FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer’s Disease
05 05 2022 The U.S. Food and Drug Administration permitted marketing for the first in vitro diagnostic test for early detection of...
Provision Consulting Group
May 5, 20224 min read
How to accelerate the FDA approval process time?
Apr 28 2022 In the medical device industry, time is the most important thing to your device market in the United States after innovation....
Provision Consulting Group
May 3, 20224 min read
Counterfeit At-Home OTC COVID-19 Diagnostic Tests
May 02 2022 The FDA is aware of counterfeit at-home over-the-counter (OTC) COVID-19 diagnostic tests being distributed or used in the...
Provision Consulting Group
May 2, 20223 min read
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