provision logo.png
  • HOME

  • FDA

  • SERVICES

    • MEDICAL DEVICES
    • DRUGS
    • QUALITY SYSTEM
    • COSMETICS
    • CLINICAL STUDIES
    • TESTING SERVICES
    • ADVISORY
  • CONTACT US

  • BLOG & NEWS

  • CAREER

  • More

    Use tab to navigate through the menu items.
    English
    English
    Spanish
    French
    Korean
    Chinese
    FDA, OTC Medical Devices Q&A for Device Manufacturers
    Provision Consulting Group
    • Apr 20

    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
    Provision Consulting Group
    • Apr 14

    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
    Provision Consulting Group
    • Apr 9

    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
    Provision Consulting Group
    • Apr 8

    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
    Provision Consulting Group
    • Apr 5

    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)
    Provision Consulting Group
    • Apr 5

    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
    Provision Consulting Group
    • Mar 29

    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...
    FDA Issues Guidance on Certain Ophthalmic Products: Policy for Compliance With 21 CFR Part 4
    Provision Consulting Group
    • Mar 28

    FDA Issues Guidance on Certain Ophthalmic Products: Policy for Compliance With 21 CFR Part 4

    Mar 28 2022 The U.S. Food and Drug Administration(FDA) issued the guidance for industry, Certain Ophthalmic Products: Policy Regarding...
    FDA, Additional Procedural Notice on Consumer Research on “Healthy” Symbol
    Provision Consulting Group
    • Mar 25

    FDA, Additional Procedural Notice on Consumer Research on “Healthy” Symbol

    Mar 25 2022 FDA Issues Additional Procedural Notice on Consumer Research on “Healthy” Symbol. The U.S. Food and Drug Administration is...
    FDA, COVID-19 Policies for Manufacturing Hand Sanitizer
    Provision Consulting Group
    • Mar 25

    FDA, COVID-19 Policies for Manufacturing Hand Sanitizer

    Mar 25 2022 FDA is reminding companies that manufactured alcohol-based hand sanitizers consistent with FDA’s temporary policies (guidance...
    FDA approves Pluvicto for metastatic castration-resistant prostate cancer
    Provision Consulting Group
    • Mar 24

    FDA approves Pluvicto for metastatic castration-resistant prostate cancer

    Mar 24 2022 On March 23, 2022, the Food and Drug Administration approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, Advanced...
    FDA, Mercury Poisoning Linked to Skin Products
    Provision Consulting Group
    • Mar 24

    FDA, Mercury Poisoning Linked to Skin Products

    Mar 23 2022 The U.S. Food and Drug Administration cautions that you should avoid skin creams, beauty and antiseptic soaps, and lotions...
    Proposed Rule: Quality System Regulation Amendments FAQs
    Provision Consulting Group
    • Mar 21

    Proposed Rule: Quality System Regulation Amendments FAQs

    Mar 21 2022 On February 23, 2022, the FDA issued a proposed rule to amend the device current good manufacturing practice (CGMP)...
    The Generic Drug Approval Process
    Provision Consulting Group
    • Mar 17

    The Generic Drug Approval Process

    Mar 17 2022 FDA requires a generic drug company to produce enough data to demonstrate the company can make a drug that can be...
    FDA, FY 2022 OTC Monograph Drug User Fee(OMUFA)
    Provision Consulting Group
    • Mar 15

    FDA, FY 2022 OTC Monograph Drug User Fee(OMUFA)

    Mar 14 2022 On March 14, 2022, FDA announced the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2022. OTC...
    FDA, guidance of Pre-Submission
    Provision Consulting Group
    • Mar 14

    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...
    FDA Clinical Trial Guidances for Advancing Development of Cancer Treatments
    Provision Consulting Group
    • Mar 9

    FDA Clinical Trial Guidances for Advancing Development of Cancer Treatments

    Mar 08 2022 March 01 2022, the U.S. Food and Drug Administration issued three final guidances to industry regarding cancer clinical...
    FDA, CDER's Drug Approvals and Programming to Speed Therapeutic Development
    Provision Consulting Group
    • Mar 8

    FDA, CDER's Drug Approvals and Programming to Speed Therapeutic Development

    Mar 07 2022 FDA I Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research A rare disease is any disease that...
    OTC Monograph Reform: Overview of Draft Guidance for Formal Meetings
    Provision Consulting Group
    • Mar 7

    OTC Monograph Reform: Overview of Draft Guidance for Formal Meetings

    Mar 07 2022 Date: March 29, 2022 Time: 2:00 PM - 3:00 PM ET ABOUT THIS WEBINAR During this webinar, FDA will provide an overview of the...
    FDA Regulation, Soaps & Lotions
    Provision Consulting Group
    • Mar 3

    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...
    1
    2345
     
    • YouTube
    • Facebook
    • Instagram

    ©2022 Provision Consulting Group, Inc. | All Rights Reserved.

    Address: 100 Barranca St. Suite 700, West Covina, CA 91791 | Phone: +1-909-493-3276 | Email: ask@provisionfda.com