Provision Consulting GroupApr 20FDA, OTC Medical Devices Q&A for Device ManufacturersApr 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 GroupApr 14FDA Authorizes First COVID-19 Diagnostic Test Using Breath SamplesApr 14 2022 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic...
Provision Consulting GroupApr 9In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2Apr 08 2022 Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2 This table includes information about authorized SARS-CoV-2...
Provision Consulting GroupApr 8FDA approves alpelisib for PIK3CA-related overgrowth spectrumApr 06 2022 On April 5, 2022, the Food and Drug Administration granted accelerated approval to alpelisib (Vijoice, Novartis...
Provision Consulting GroupApr 5FDA updates Sotrovimab emergency use authorizationApr 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 GroupApr 5FY 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 GroupMar 29Allergens in CosmeticsMar 29 2022 Cosmetic products (such as soaps, lotions, face and eye make up, fragrances, etc.) can provoke allergic reactions in some...
Provision Consulting GroupMar 28FDA Issues Guidance on Certain Ophthalmic Products: Policy for Compliance With 21 CFR Part 4Mar 28 2022 The U.S. Food and Drug Administration(FDA) issued the guidance for industry, Certain Ophthalmic Products: Policy Regarding...
Provision Consulting GroupMar 25FDA, Additional Procedural Notice on Consumer Research on “Healthy” SymbolMar 25 2022 FDA Issues Additional Procedural Notice on Consumer Research on “Healthy” Symbol. The U.S. Food and Drug Administration is...
Provision Consulting GroupMar 25FDA, COVID-19 Policies for Manufacturing Hand SanitizerMar 25 2022 FDA is reminding companies that manufactured alcohol-based hand sanitizers consistent with FDA’s temporary policies (guidance...
Provision Consulting GroupMar 24FDA approves Pluvicto for metastatic castration-resistant prostate cancerMar 24 2022 On March 23, 2022, the Food and Drug Administration approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, Advanced...
Provision Consulting GroupMar 24FDA, Mercury Poisoning Linked to Skin ProductsMar 23 2022 The U.S. Food and Drug Administration cautions that you should avoid skin creams, beauty and antiseptic soaps, and lotions...
Provision Consulting GroupMar 21Proposed Rule: Quality System Regulation Amendments FAQsMar 21 2022 On February 23, 2022, the FDA issued a proposed rule to amend the device current good manufacturing practice (CGMP)...
Provision Consulting GroupMar 17The Generic Drug Approval ProcessMar 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 GroupMar 15FDA, 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 GroupMar 14FDA, guidance of Pre-SubmissionWe want to give you some advice on Pre-Submission which leads to successful FDA approval. FDA offers a Pre-submission program and...
Provision Consulting GroupMar 9FDA Clinical Trial Guidances for Advancing Development of Cancer TreatmentsMar 08 2022 March 01 2022, the U.S. Food and Drug Administration issued three final guidances to industry regarding cancer clinical...
Provision Consulting GroupMar 8FDA, CDER's Drug Approvals and Programming to Speed Therapeutic DevelopmentMar 07 2022 FDA I Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research A rare disease is any disease that...
Provision Consulting GroupMar 7OTC Monograph Reform: Overview of Draft Guidance for Formal MeetingsMar 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 GroupMar 3FDA Regulation, Soaps & LotionsMar 03 2022 We provide safety and regulatory information about soaps and lotions. Lotions, soaps, and other cleansers may be regulated as...