Provision Consulting Group
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...
Provision Consulting Group
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...
Provision Consulting Group
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...
Provision Consulting Group
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...
Provision Consulting Group
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...
Provision Consulting Group
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...
Provision Consulting Group
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...
Provision Consulting Group
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...
Provision Consulting Group
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...
Provision Consulting Group
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...
Provision Consulting Group
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...
Provision Consulting Group
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...
Provision Consulting Group
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)...
Provision Consulting Group
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...
Provision Consulting Group
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...
Provision Consulting Group
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...
Provision Consulting Group
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...
Provision Consulting Group
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...
Provision Consulting Group
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...
Provision Consulting Group
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...