• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 25
    • Directory
    • Microsites
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 25
  • Directory
  • Microsites
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    Bye-Bye China?

    Decentralized Trials Fuel AI Revolution in Clinical Research

    Self-Medication: Flexibility for Patients and Drug Manufacturers

    The Single-Use Mixing Landscape: Evaluating Your Options

    DCAT President Talks COVID-19, Drug Manufacturing and Innovation
    Breaking News
    Online Exclusives
    Industry News
    Collaborations & Alliances
    Promotions & Moves
    Trials & Filings
    Financial Reports
    Bio News & Views
    Custom Sourcing News
    Packaging & Tracking
    CRO News
    Live From Shows
    Top News
    Global Biosciences Co. Selects ValGenesis VLMS

    Eisai Appoints Chief Clinical Officer of Oncology Biz

    Nexelis Acquires GSK Vax Lab in Marburg

    Bone Therapeutics, Rigenerand Ink Cell Therapy Deal

    NovaQuest Private Equity Acquires CoreRx
    APIs
    Aseptic Processing
    Cleaning Validation
    Clinical Trial Materials
    Cytotoxics and High Potency Manufacturing
    Equipment
    Excipients
    Extractables and Leachables
    Facilities
    Fill/Finish
    Lyophilization
    Parenterals
    Process Development
    Process Validation
    Risk Management
    Scale-up/ Technology Transfer
    Solid Dosage/ Creams/ Ointments

    Lonza to Exit Pharma Softgels and Liquid-Filled Hard Capsules

    Cognate BioServices Announces Major Expansion

    Sanofi Unveils EUROAPI as Name of New European API Company

    Precision Medicine Group Acquires Project Farma

    Cytiva Delivers Modular Biologics Factory to Lonza
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Catalent Acquires Acorda’s INBRIJA Manufacturing Operations

    Varcode, PL Developments Form Strategic ‘Smart Tag’ Pact

    COVID-19 Vaccine Distribution: The Air Cargo Industry’s Greatest Challenge

    Thermo Fisher Expands Clinical Supply Services in Europe

    Schreiner MediPharm Joins DoseID Consortium
    Analytical Services
    Bioanalytical Services
    Bioassay Developement
    Biologics, Proteins, Vaccines
    Biosimilars
    Chemistry
    Clinical Trials
    Drug Delivery
    Drug Development
    Drug Discovery
    Formulation Development
    Information Technology
    Laboratory Testing
    Methods Development
    Microbiology
    Preclinical Outsourcing
    R&D
    Toxicology

    Global Biosciences Co. Selects ValGenesis VLMS

    Nexelis Acquires GSK Vax Lab in Marburg

    The Future of Clinical Trials Series: Part I

    JS Bio and Etta Biotech Advancing Partnership

    Intravacc Completes Project for Provention Bio’s Vax Candidate
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    Global Biosciences Co. Selects ValGenesis VLMS

    Gene Therapy Co. Selects ValGenesis' SaaS Platform

    The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021

    CDMO Cognate BioServices Teams Up with L7 Informatics

    Samsung Biologics Adopts Veeva Vault QMS to Unify Quality Management
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    Aphena Pharma Solutions

    Emergent BioSolutions

    Syngene

    Baxter BioPharma Solutions

    Adare Pharma Solutions
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Aphena Pharma Solutions

    Alcami

    Adare Pharma Solutions

    Reed-Lane

    Cytovance Biologics
    Webinars
    Live From Shows
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • Enewsletter Archive
      • Digital Edition
    • Directory
      • Companies
      • Categories
      • Corporate Capabilities
      • Add Your Company
    • Manufacturing
      • APIs
      • Aseptic Processing
      • Cleaning Validation
      • Clinical Trial Materials
      • Cytotoxics and High Potency Manufacturing
      • Equipment
      • Excipients
      • Extractables and Leachables
      • Facilities
      • Fill/Finish
      • Lyophilization
      • Parenterals
      • Process Development
      • Process Validation
      • Risk Management
      • Scale-up/ Technology Transfer
      • Solid Dosage/ Creams/ Ointments
      • cGMP Manufacture
    • Packaging
      • Capsules
      • Cold Chain Management
      • Injectables
      • Logistics
      • Serialization
      • Solid Dosage / Semi-solids
      • Supply Chain
      • Vials
    • Development
      • Analytical Services
      • Bioanalytical Services
      • Bioassay Developement
      • Biologics, Proteins, Vaccines
      • Biosimilars
      • Chemistry
      • Clinical Trials
      • Drug Delivery
      • Drug Development
      • Drug Discovery
      • Formulation Development
      • Information Technology
      • Laboratory Testing
      • Methods Development
      • Microbiology
      • Preclinical Outsourcing
      • R&D
      • Toxicology
    • Compliance
      • Filtration & Purification
      • GMPs/GCPs
      • Inspections
      • QA/QC
      • Regulatory Affairs
      • Validation
    • Top 25 Pharma & BioPharma
    • Contract Pharma Direct
    • Breaking News
    • Online Exclusives
    • Slideshows
    • Experts Opinions
    • Surveys
      • Outsourcing Survey
      • Salary Survey
    • Glossary
    • Videos
    • Podcasts
    • White Papers
    • Infographics
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Conference Sessions
    • Supplier Microsite
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • eBook
    • Webinars
    • Events
      • Industry Events
      • Live from Show Events
      • Webinars
    • Classifieds / Job Bank
      • Classifieds
      • Job Bank
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Breaking News

    FDA COVID-19 Update

    Issues guidance highlighting flexibility under the Drug Supply Chain Security Act

    Related CONTENT
    • Mogene
    Contract Pharma Staff05.01.20

    The U.S. FDA has taken the following action as of April 30th in the ongoing response effort to the COVID-19 pandemic: 

    • Tthe FDA included, under the ventilator emergency use authorization (EUA), a ventilator developed by the National Aeronautics and Space Administration (NASA), which is tailored to treat patients with COVID-19. The ventilator was added to the list of authorized ventilators, ventilator tubing connectors and ventilator accessories under the ventilator EUA that was issued in response to concerns relating to insufficient supply and availability of FDA-cleared ventilators for use in health care settings to treat patients during the COVID-19 pandemic.
    • The FDA issued a Consumer Update, Helpful Questions and Answers about Coronavirus (COVID-19) and Your Pets, that provides answers to frequently asked questions. Based on the limited information available to date, the risk of pets spreading the virus that causes COVID-19 in people is considered to be low.
    • The FDA issued a guidance highlighting flexibility under the Drug Supply Chain Security Act (DSCSA). This guidance is intended to facilitate the distribution of prescription drug products needed to respond to COVID-19, including drugs to treat symptoms of COVID-19. During the COVID-19 emergency, the DSCSA requirements related to certain product tracing and product identification activities, and wholesale distribution, do not apply to qualifying distribution activities. This flexibility balances the need for effective distribution of products under emergency conditions with protecting consumers from exposure to products that may be counterfeit, stolen or otherwise harmful.
    • Diagnostics Update to Date 
      • During the COVID-19 pandemic, the FDA has worked with more than 380 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. 
      • To date, the FDA has issued 53 individual emergency use authorizations for test kit manufacturers and laboratories. In addition, 23 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs). 
      • The FDA has been notified that more than 235 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance. 
      • The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.
    Suggested For You
    Mogene Mogene

    Related Breaking News

    • Breaking News | Industry News | Information Technology | Validation
      Global Biosciences Co. Selects ValGenesis VLMS

      Global Biosciences Co. Selects ValGenesis VLMS

      Will digitize the validation service activities for efficient and faster access to validated and safer products across 40 countries.
      Contract Pharma Staff 01.20.21

    • Breaking News | Promotions & Moves
      Eisai Appoints Chief Clinical Officer of Oncology Biz

      Eisai Appoints Chief Clinical Officer of Oncology Biz

      Dr. Richard Woodman has 18 years of pharmaceutical experience in several different functional areas at both large and small biotech organizations.
      Contract Pharma Staff 01.20.21

    • Bioanalytical Services | Biologics, Proteins, Vaccines | Breaking News | Industry News
      Nexelis Acquires GSK Vax Lab in Marburg

      Nexelis Acquires GSK Vax Lab in Marburg

      Enters into a 5-year strategic agreement to support the development of future GSK vaccine candidates.
      Contract Pharma Staff 01.20.21


    • Bio News | Breaking News | Collaborations & Alliances | Industry News
      Bone Therapeutics, Rigenerand Ink Cell Therapy Deal

      Bone Therapeutics, Rigenerand Ink Cell Therapy Deal

      Enter an agreement for a process development partnership.
      Contract Pharma Staff 01.19.21

    • Breaking News | Industry News
      NovaQuest Private Equity Acquires CoreRx

      NovaQuest Private Equity Acquires CoreRx

      New strategic financial sponsor to support continued growth and capability expansion.
      Contract Pharma Staff 01.19.21

    • Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
      JS Bio and Etta Biotech Advancing Partnership

      JS Bio and Etta Biotech Advancing Partnership

      Will set up a high titer transient protein expression platform for high quality protein production.
      Contract Pharma Staff 01.19.21


    • Bio News | Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Collaborations & Alliances | Industry News
      Intravacc Completes Project for Provention Bio’s Vax Candidate

      Intravacc Completes Project for Provention Bio’s Vax Candidate

      Potentially the first preventive vaccine for coxsackievirus B, a risk factor associated with type 1 diabetes and celiac disease.
      Contract Pharma Staff 01.19.21

    • Breaking News | Facilities | Industry News | Solid Dosage/Creams/Ointments
      Lonza to Exit Pharma Softgels and Liquid-Filled Hard Capsules

      Lonza to Exit Pharma Softgels and Liquid-Filled Hard Capsules

      NextPharma to acquire sites in France and UK specialized in lipid oral finished dosage forms.
      Contract Pharma Staff 01.19.21

    • Promotions & Moves
      Valeo Pharma Appoints President, COO

      Valeo Pharma Appoints President, COO

      Frederic Fasano brings 25 years of experience to the newly created position.
      Contract Pharma Staff 01.18.21


    • Breaking News | Collaborations & Alliances | Drug Discovery
      Metrion, LifeArc Extend Neuroscience Alliance

      Metrion, LifeArc Extend Neuroscience Alliance

      Collaboration extended for another 12 months after successfully progressing into late stage hit-to-lead optimization phase.
      Contract Pharma Staff 01.18.21

    • Breaking News | Clinical Trials | Industry News
      Grifols Begins COVID-19 Plasma Treatment Trial

      Grifols Begins COVID-19 Plasma Treatment Trial

      Treatment could be used for people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease, complementing the vaccine.
      Contract Pharma Staff 01.18.21

    • Breaking News | Collaborations & Alliances | Drug Development | Drug Discovery
      Janssen, TenNor Enter NTM Research Pact

      Janssen, TenNor Enter NTM Research Pact

      To leverage TenNor’s multitargeting drug conjugation platform to discover new therapies to treat nontuberculous mycobacteria diseases.
      Contract Pharma Staff 01.18.21


    • Breaking News | Industry News
      KORSCH, MEDELPHARM Partner on R&D Equipment Portfolio

      KORSCH, MEDELPHARM Partner on R&D Equipment Portfolio

      New lineup aims to address challenges from early stage powder characterization and formulation development to scale-up and production.
      Contract Pharma Staff 01.15.21

    • Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News
      Cognate BioServices Announces Major Expansion

      Cognate BioServices Announces Major Expansion

      Will increase cell and gene therapy manufacturing capacity, laboratory space, warehousing capabilities and more.
      Contract Pharma Staff 01.15.21

    • Breaking News | Collaborations & Alliances | CRO News | Industry News
      Bioclinica Partners with Ikcon Pharma

      Bioclinica Partners with Ikcon Pharma

      Will work together to deliver best-in-class e-clinical solutions to the pharma industry & sponsors.
      Contract Pharma Staff 01.15.21

    Trending
    • Lonza To Exit Pharma Softgels And Liquid-Filled Hard Capsules
    • Roche Canada To Invest $500M To Create 500 Jobs In Ontario
    • Grifols Begins COVID-19 Plasma Treatment Trial
    • Fujifilm To Invest $2B In US Manufacturing Site
    • Virtual Clinical Trials: The Future Of Dermatology Studies
    Breaking News
    • Global Biosciences Co. Selects ValGenesis VLMS
    • Eisai Appoints Chief Clinical Officer of Oncology Biz
    • Nexelis Acquires GSK Vax Lab in Marburg
    • Bone Therapeutics, Rigenerand Ink Cell Therapy Deal
    • NovaQuest Private Equity Acquires CoreRx
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Modeling Process Safety Workflows in Pharmaceutical Manufacturing Scale-Up
    • Ensuring Quality During the Transfer and Scale Up of Rx Drugs
    • Inspecting the Unexpected
    • Cold Chain Trends
    • Catering for the Complex
    • Biopharma Contract Manufacturing: Robust Growth Ahead
    • DCAT President Talks COVID-19, Drug Manufacturing and Innovation
    • The Single-Use Mixing Landscape: Evaluating Your Options
    • Self-Medication: Flexibility for Patients and Drug Manufacturers
    • Decentralized Trials Fuel AI Revolution in Clinical Research
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Ingredient Manufacturers Discuss the E-Sports Market
    Euromonitor Names Top Ten Trends for 2021
    Study Highlights Differences Between EPA's and DHA's Effect on Sleep
    Coatings World

    Latest Breaking News From Coatings World

    IGL Coatings Launches Graphene Reinforced Dual System Ceramic Coating
    Miller Paint Declares Simple Serenity its 2021 Color of the Year
    TAUBMANS Paint by PPG Releases ‘Chromatic Joy’ Palettes
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Eitan Medical Receives FDA Clearance for Sapphire Infusion System
    Researchers Successfully ‘Fine Tune’ New Thermoplastic Biomaterial
    RSIP Vision Announces Versatile Medical Image Segmentation Tool
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Global Biosciences Co. Selects ValGenesis VLMS
    Eisai Appoints Chief Clinical Officer of Oncology Biz
    Nexelis Acquires GSK Vax Lab in Marburg
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Top Beauty Brands in the World—And Most Loved Fragrances
    P&G Reports Q2 Results
    A Lacquering Technique Makes Very Good Girl by Carolina Herrera Shine
    Happi

    Latest Breaking News From Happi

    Flow Launches Collagen Waters
    David Stanko Joins JPMS
    Ross Introduces Double Cone Tumble Blender
    Ink World

    Latest Breaking News From Ink World

    Morancé Soudure France Adds Comexi F2 MC 10-color Flexo Press
    THIMM Group Installs 1st Koenig & Bauer CorruFLEX
    Cowan Graphics Adds Fujifilm Inca OnsetX3 HS
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Domino grows installation and service teams
    ABG keeps pace with demand with recruitment drive
    Acucote expands FSC-certified portfolio
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    First Quality Launches Incognito by Prevail
    Essity Launches Reusable Underwear Product
    Honeywell Delivered 225 Million Masks in December
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    DJO Acquires Trilliant Surgical
    FDA Breakthrough Device Designation Granted to Spiderwort's Spinal Cord Technology
    Bioventus Appoints SVP of Operations
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    UDC Subsidiary Adesis' Website Wins 2020 MarCom Platinum Award
    Roadsimple Modernizes Warehouse Ops with Zebra Technologies
    Graphene Flagship Launches Redesigned Website

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login