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NEWS & BLOGS
Blog: Blog2
What to know FDA Import Alerts & Import Refusals?
January 27 2023 Import Alerts notifies that a product is subject to detention without physical examination (DWPE) because it violates or...
Provision Consulting Group
Jan 27, 20232 min read
FDA New Cosmetics Regulation: MoCRA (Modernization of Cosmetics Regulation Act)
January 25, 2023 On December 29, 2022, The president signed a new law: the Modernization of Cosmetics Regulation Act of 2022 (MoCRA),...
Provision Consulting Group
Jan 25, 20232 min read
What to know FDA regulation before Cosmetic products go on the U.S. market?
January 6 2023 Among the important differences between requirements for cosmetics in the United States and various other countries are...
Provision Consulting Group
Jan 6, 20233 min read
What should I expect during an FDA audit?
January 5, 2023 Under the Federal Food, Drug and Cosmetic Act, the FDA is required to inspect manufacturers at least once every two years...
Provision Consulting Group
Jan 5, 20232 min read
FDA Medical Device: How to prepare a 510(k)?
January 04 2023 There are three types of Premarket Notification 510(k)s that may be submitted to the FDA: Traditional, Special, and...
Provision Consulting Group
Jan 4, 20233 min read
FDA, Classify Your Medical Device
December 29 2022 There are a number of pathways available to bring a medical device to market. The regulatory pathway for a specific...
Provision Consulting Group
Dec 29, 20222 min read
FDA, What does FDA consider in determining whether to classify a product as a drug or device?
December 28 2022 FDA’s determination of whether to classify a product as a drug or device is based on statutory definitions, as set forth...
Provision Consulting Group
Dec 28, 20222 min read
FDA Medical Device, Frequently Asked Questions for (OTC) Device Manufacturers
December 23 2022 Over-the-counter (OTC) medical devices are those that may be offered for sale directly to the consumer. In other words,...
Provision Consulting Group
Dec 23, 20223 min read
FDA Medical Device, Quality System and cGMP
December 22 2022 Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable...
Provision Consulting Group
Dec 22, 20224 min read
Provision Consulting Group signed a Memorandum of Understanding (MOU) with POSCO International
Nov. 30 2022 On November 16th, Provision Consulting Group, Inc., which specializes in consultation on FDA approval for bio-healthcare and...
Provision Consulting Group
Nov 30, 20222 min read
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