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,...
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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February 17 2023 On February 17, 2023, FDA published a new draft guidance for industry, “Product-Specific Guidance Meetings Between FDA...
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...
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...
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...
FDA New Cosmetic Regulation : Modernization of Cosmetics Regulation Act
January 25 2023 On December 29, 2022, The president signed into law: The modernization of Cosmetics Regulation Act of 2022 (MOCRA) which...
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...
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...
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...
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 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...
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...
Reminder: FDA New Medical Device User Fees for FY 2023
Nov 07 2022 On October 5th, 2022, the FDA has announced the Fiscal Year (FY) 2023 fees under the MDUFA (Medical Device User Fee...
FDA, OTC Medical Devices Q&A for Device Manufacturers
Apr 20 2022 Over-the-counter (OTC) medical devices are those that may be offered for sale directly to the consumer. In other words, these...
FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples
Apr 14 2022 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic...
In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2
Apr 08 2022 Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2 This table includes information about authorized SARS-CoV-2...
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...
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...
FY 2023-2027 FDA Medical Device User Fee Amendment (MDUFA V)
Apr 04 2022 On April 19, 2022, the United States Food and Drug Administration(FDA) will provide a virtual MDUFA V public meeting that is...
Allergens in Cosmetics
Mar 29 2022 Cosmetic products (such as soaps, lotions, face and eye make up, fragrances, etc.) can provoke allergic reactions in some...
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