FDA, guidance of Pre-Submission
We want to give you some advice on Pre-Submission which leads to successful FDA approval. FDA offers a Pre-submission program and...
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NEWS & BLOGS
Blog: Blog2
Provision Consulting Group
Mar 3, 20224 min read
FDA Regulation, Soaps & Lotions
Mar 03 2022 We provide safety and regulatory information about soaps and lotions. Lotions, soaps, and other cleansers may be regulated as...
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Provision Consulting Group
Mar 2, 20223 min read
FDA Regulation, Cosmetics or Drugs?
Mar 02 2022 The Food and Drug Administration (FDA) warns cosmetics companies when they make claims about their products that classify...
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Provision Consulting Group
Feb 22, 20221 min read
FDA, At-Home OTC COVID-19 Diagnostic Tests
Feb 22 2022 FDA provides information about at-home over-the-counter (OTC) COVID-19 diagnostic tests. These at-home COVID-19 diagnostic...
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Provision Consulting Group
Feb 16, 20225 min read
FDA Regulation, Development & Approval Process | Drugs
Feb 10 2022 Developing New Drugs American consumers benefit from having access to the safest and most advanced pharmaceutical system in...
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Provision Consulting Group
Feb 15, 20224 min read
FDA Regulation, hand sanitizer
Feb 15 2022 FDA is working with U.S. government partners including the Centers for Disease Control and Prevention (CDC), medical product...
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Provision Consulting Group
Feb 14, 20224 min read
FDA Regulation, Medical Device Classification
Feb 14 2022 The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of...
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Provision Consulting Group
Feb 14, 20224 min read
FDA, New Monoclonal Antibody for Treatment of COVID-19 that Retains Activity Against Omicron Variant
Feb 14 2022 02/11/2022, The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for a new monoclonal antibody...
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Provision Consulting Group
Feb 10, 20224 min read
What Is the Approval Process for Generic Drugs?
Feb 10 2022 Generic drugs are copies that one company makes of a brand-name drug that was developed by another company. Generally,...
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Provision Consulting Group
Feb 9, 20222 min read
Medical Device, FDA Regulations required for export to the US
Feb 09 2022 When exporting medical devices to the US, what are the regulations? All medical devices imported into the United States...
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Provision Consulting Group
Feb 7, 20225 min read
FDA Regulations : Cosmetics Labeling
Feb 07 2022 This section provides resources on regulatory requirements for cosmetic labeling. For a thorough explanation of cosmetic...
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Provision Consulting Group
Jan 27, 20224 min read
FDA Regulation, Face Mask
N95 respirators and surgical masks are examples of personal protective equipment that are used to protect the wearer from particles or...
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Provision Consulting Group
Jan 25, 20223 min read
FDA, Combination Product Regulation
FDA expects to receive large numbers of combination products for review as technological advances continue to merge product types and...
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Provision Consulting Group
Jan 24, 20224 min read
FDA, Medical Gloves Regulation
Medical gloves are used by health care personnel to prevent the spread of infection or illness. Medical gloves are disposable and include...
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Provision Consulting Group
Jan 20, 20225 min read
FDA Regulatory : Medical Device Bans
What is a Medical Device Ban? A medical device ban is a total prohibition on the current and future sales, distribution, and...
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Provision Consulting Group
Jan 19, 20227 min read
FDA Regulatory, Color Additives and Cosmetics
Color additives are subject to a strict system of approval under U.S. law [Federal Food, Drug, and Cosmetic Act (FD&C Act), sec. 721; 21...
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Provision Consulting Group
Jan 18, 20223 min read
FDA, Cochlear Implant
Medical implants are devices or tissues that are placed inside or on the surface of the body. Many implants are prosthetics, intended to...
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Provision Consulting Group
Jan 12, 20228 min read
Small Business Assistance : Regulatory Process of Over-the-Counter (OTC) Drugs
1. What is an Over-the-Counter (OTC) Drug Product? An OTC drug product is a drug product marketed for use by the consumer without the...
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Provision Consulting Group
Jan 11, 20223 min read
COVID-19 Vaccine Booster Shots
Choosing Your COVID-19 Booster Shot Three COVID-19 vaccines are authorized or approved for use in the United States to prevent COVID-19....
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Provision Consulting Group
Jan 6, 20222 min read
Novel Drug Approvals for 2021
Innovative drugs often mean new treatment options for patients and advances in health care for the American public. When it comes the...
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