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NEWS & BLOGS
Blog: Blog2
The difference between FDA Registered, FDA Cleared, and FDA Approved
When examining advertisements for medical devices, it is common to come across the phrase "FDA approved" to enhance the credibility and...
Provision Consulting Group
May 31, 20232 min read
How Should Cosmetics Companies Prepare for MoCRA?
Updated on 9/7/23. On December 29, 2022, the FDA enacted "The Modernization of Cosmetics Regulation Act (MOCRA)." The critical of the...
Provision Consulting Group
May 24, 20232 min read
FDA approves treatment of amyotrophic lateral sclerosis associated with a mutation in the SOD1 gene
The FDA approved a treatment for individuals who have amyotrophic lateral sclerosis (ALS) and carry a specific genetic mutation known as...
Provision Consulting Group
Apr 26, 20231 min read
Modernization of Cosmetics Regulation Act of 2022 (MOCRA)
On March 27, 2023, the FDA update announced that has stopped accepting submissions to the Voluntary Cosmetic Registration Program(VCRP)...
Provision Consulting Group
Apr 19, 20232 min read
![[FDA News] Public Meeting: Good Manufacturing Practices for Cosmetic Products](https://static.wixstatic.com/media/7ffba2_3f0d4e9206cd4f7b9678fb390a3ded41f000.jpg/v1/fill/w_767,h_576,fp_0.50_0.50,lg_1,q_30,blur_30,enc_avif,quality_auto/7ffba2_3f0d4e9206cd4f7b9678fb390a3ded41f000.jpg)
![[FDA News] Public Meeting: Good Manufacturing Practices for Cosmetic Products](https://static.wixstatic.com/media/7ffba2_3f0d4e9206cd4f7b9678fb390a3ded41f000.jpg/v1/fill/w_767,h_576,fp_0.50_0.50,lg_1,q_90,enc_avif,quality_auto/7ffba2_3f0d4e9206cd4f7b9678fb390a3ded41f000.jpg)
[FDA News] Public Meeting: Good Manufacturing Practices for Cosmetic Products
FDA will have a public meeting for good manufacturing practices for cosmetic products. Please save the date: The U.S. Food and Drug...
Provision Consulting Group
Apr 19, 20231 min read
FDA has Stopped Voluntary Cosmetic Registration Program(VCRP) to the Mandatory Cosmetic Registration
April 5 2023 On March 27, 2023, the FDA update announced that has stopped accepting submissions to the Voluntary Cosmetic Registration...
Provision Consulting Group
Apr 5, 20232 min read
FDA Guidance, Clinical Decision Support Software(CDS)
February 22 2023 The US Food and Drug Administration has released final guidance for clinical decision software (CDS) functions,...
Provision Consulting Group
Feb 22, 20232 min read
Product-Specific Guidance Meeting between FDA and ANDA applicants
February 17 2023 On February 17, 2023, FDA published a new draft guidance for industry, “Product-Specific Guidance Meetings Between FDA...
Provision Consulting Group
Feb 17, 20232 min read
FDA Regulatory Focus on Compounding Children's Ibuprofen in Response to Increased Demand
February 10 2023 The guidance issued by the Food and Drug Administration (FDA) was released due to an increase in demand for pediatric...
Provision Consulting Group
Feb 10, 20232 min read
FDA Compliance Label Review, How vital is it?
Feburary 08 2023 The U.S. Food and Drug Administration (FDA) develops and administers regulations under authority granted by laws passed...
Provision Consulting Group
Feb 8, 20232 min read
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
An Overview of 510(k) Electronic Submission Guidance for FDA 510(k) Submissions
Nov 11 2022 On October 3, 2022 the FDA announced that sending electronic copy (eCopy) or electronic Submission Template And Resource...
Provision Consulting Group
Nov 11, 20222 min read
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