• 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
    Bone Therapeutics, Rigenerand Ink Cell Therapy Deal

    NovaQuest Private Equity Acquires CoreRx

    JS Bio and Etta Biotech Advancing Partnership

    Intravacc Completes Project for Provention Bio’s Vax Candidate

    Lonza to Exit Pharma Softgels and Liquid-Filled Hard Capsules
    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

    The Future of Clinical Trials Series: Part I

    JS Bio and Etta Biotech Advancing Partnership

    Intravacc Completes Project for Provention Bio’s Vax Candidate

    Drug Development For Startups

    Metrion, LifeArc Extend Neuroscience Alliance
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    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

    Samsung Biologics Adopts Veeva Vault QMS to Unify Quality Management

    CDMO Cognate BioServices Teams Up with L7 Informatics

    The Wasdell Group Earns ISO 13485 Certification
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    PCI Pharma Services

    Syngene

    Aphena Pharma Solutions

    Reed-Lane

    Baxter BioPharma Solutions
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Alcami

    Cytovance Biologics

    Emergent BioSolutions

    Adare Pharma Solutions

    Syngene
    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
    Columns

    GDUFA II Update

    At the negotiating table with FDA and other trade groups

    Related CONTENT
    • Mogene
    • Recro Gainesville Expands Mfg. Capabilities
    • Diverse Products And Technologies Delivered
    • PPD Expands Vaccine Development Lab
    • UPM Celebrates 100-Years of Mfg. at Tennessee Site
    Gil Roth, President, Pharma & Biopharma Outsourcing Association10.13.16
    It’s been about six months since I last checked in with news from the Pharma & Biopharma Outsourcing Association (PBOA). At the time, the PBOA was immersed in negotiations with FDA and other industry groups for the reauthorization of the Generic Drug User Fee Amendments (GDUFA). Because negotiations were ongoing, I couldn’t discuss how they were progressing—beyond the need for confidentiality, it was also a very fluid process.

    Now, I’m happy to report, industry’s negotiations with FDA have concluded! However, I still can’t go into much detail, pending FDA’s disclosure of the proposed five-year reauthorization model. In mid-September, the agency did reveal some details of the proposal in a Federal Register notice, in advance of an October public meeting for comment prior to submission to Congress. Much of the FR notice discussed operational improvements for GDUFA II, regarding timelines for first reviews of Abbreviated New Drug Applications (ANDAs), a priority model that would shave two months off of the first review cycle—provided the applicant provides a pre-submission facility correspondence two months prior to ANDA submission—and consolidation of all ANDAs and ANDA amendments in a way that will streamline the program’s administration.
    The agency also proposes to communicate outstanding facility issues more quickly to ANDA filers; PBOA worked to make sure they’ll respect the confidentiality of CMO facilities and their clients.

    CMOs and CDMOs may be less directly impacted by these enhancements than the ANDA filers are, but PBOA was glad to be part of the conversation throughout the process and to develop a better understanding of the bottlenecks in ANDA reviews, the dynamics between the generics industry and the FDA, and the ways in which facility inspections are changing under FDA’s inspectorate overhaul and risk-based model.

    PBOA’s primary goal at the negotiations was to rework the GDUFA funding model into a fairer, more equitable system that would provide FDA with sustainable and predictable resources for the GDUFA program over the next five years. Again, I can’t go into detail—size of the program and percentages allocated to each revenue source—but the FR notice does mention several key proposed changes to the fee structure that should go a long way to achieving our goal:
    1. An annual “program fee” for ANDA-holding entities — ANDA sponsors will pay a tiered fee based on their total number of approved ANDAs.
    2. “No fee until approval” — A facility listed only in pending ANDAs will not be charged a facility fee. For CMOs, that means no paying annual facility fees on a facility that’s waiting for a first ANDA approval.
    3. CMO Final Dosage Form (FDF) facilities will pay one-third of the fee paid by non-CMO FDF facilities.
    These are significant changes to the program, and they were the result of extensive negotiations among industry groups and FDA. I believe they’ll create an environment where CMOs and contract packaging organizations (CPOs) can compete more effectively in making generic drugs for sponsors. The reduced CMO facility fee and the elimination of fee-while-pending, which has resulted in CMOs paying multiple years of facility fees without a revenue-generating product at their sites, will benefit our sector over the next five-year GDUFA period, pending Congressional approval, and help create a more robust, flexible manufacturing network for generic drugs.

    We couldn’t have achieved this without the support of PBOA’s member companies and the CMO/CDMO sector overall. At the same time, it required a leap of faith on the part of FDA to bring us into the negotiation. As the new kids at the table, PBOA was treated respectfully by the other participants, and I believe that this experience, over and above the immediate changes to the GDUFA program, will help our sector work more closely with industry and FDA. Our team’s professionalism and diligence not only helped us achieve our goals, but also demonstrated to the FDA that PBOA is a group they can work with in future.

    In fact, our work on GDUFA helped bring about a very positive meeting between the PBOA and Janet Woodcock, M.D., the director of FDA’s Center for Drug Evaluation and Research (CDER), and her team. I’ll tell you more about that next time I check in.


    Gil Roth
    President, Pharma & Biopharma Outsourcing Association

    Gil Roth is the president of the Pharma & Biopharma Outsourcing Association (www.pharma-bio.org), a non-profit trade association representing the regulatory and legislative interests of CMOs and CDMOs. He can be reached at gil.roth@pharma-bio.org.
    Suggested For You
    Mogene Mogene
    Recro Gainesville Expands Mfg. Capabilities Recro Gainesville Expands Mfg. Capabilities
    Diverse Products And Technologies Delivered Diverse Products And Technologies Delivered
    PPD Expands Vaccine Development Lab PPD Expands Vaccine Development Lab
    UPM Celebrates 100-Years of Mfg. at Tennessee Site UPM Celebrates 100-Years of Mfg. at Tennessee Site
     Vantage Consulting is First Systems Integrator to Join PBOA Vantage Consulting is First Systems Integrator to Join PBOA
    Whither Washington? Whither Washington?
    The Good, the Bad, and the Donald The Good, the Bad, and the Donald
    GDUFA II Update GDUFA II Update
    CPhI’s Pre-Connect Congress Highlights Key Trends CPhI’s Pre-Connect Congress Highlights Key Trends
    FDA, Industry Form Agreement on GDUFA II FDA, Industry Form Agreement on GDUFA II
    Quality Metrics & CDMOs Quality Metrics & CDMOs
    Quality Metrics: What Does it Really Mean? Quality Metrics: What Does it Really Mean?
    Grading GDUFA Grading GDUFA
    Inventas vitam iuvat excoluisse per artes (Let us improve life through science and art) Inventas vitam iuvat excoluisse per artes (Let us improve life through science and art)

    Related Columns

    • A Potential “Marriage”

      A Potential “Marriage”

      Initiator companies and generics/CMOs working together.
      Emil W. Ciurczak, DoraMaxx Consulting 11.17.20

    • When Politics and Science Collide

      When Politics and Science Collide

      COVID-19 illustrates why science should always be a principal informer of politics to make better and smarter decisions.
      Ben Locwin, Contributing Editor 11.17.20

    • The Pandemic’s Become an Insurmountable Opportunity

      The Pandemic’s Become an Insurmountable Opportunity

      Every Cloud has a Silver Lining(?)
      Emil W. Ciurczak, Contributing Editor 10.14.20


    • Biologics, Proteins, Vaccines
      It Takes a Vaccine… To End The Pandemic [У нас есть хорошая вакцина]

      It Takes a Vaccine… To End The Pandemic [У нас есть хорошая вакцина]

      Race for the vaccines is heating up.
      Ben Locwin, Contributing Editor 09.09.20

    • cGMP Manufacture
      Keys to Biotech Success

      Keys to Biotech Success

      Four steps emerging biotech companies can take to achieve success
      Thierry Cournez, Head of End-to-End Solutions, MilliporeSigma 06.04.20

    • Analytical Services
      What Happens When the All-Clear Signal is Given?

      What Happens When the All-Clear Signal is Given?

      Maybe 3M had some good ideas?
      Emil W. Ciurczak, DoraMaxx Consulting 06.04.20


    • Almost Like the Olympics:

      Almost Like the Olympics:

      “Smaller, Faster, Smarter”
      Emil W. Ciurczak, DoraMaxx Consulting 05.05.20

    • Rapid Delivery of Medical Countermeasures Amid Pandemic

      Rapid Delivery of Medical Countermeasures Amid Pandemic

      Robert Erwin of iBio discusses the company’s COVID-19 vaccine development efforts and FastPharming manufacturing platform for the rapid delivery of vaccines
      Kristin Brooks, Managing Editor, Contract Pharma 05.05.20

    • The Supply Chain House of Cards

      The Supply Chain House of Cards

      The COVID-19 pandemic exposes pressures on extended global supply chains
      Emil W. Ciurczak, DoraMaxx Consulting 04.01.20


    • Analytical Services | Laboratory Testing
      The Supply Chain, as Developed by IKEA (some assembly required)

      The Supply Chain, as Developed by IKEA (some assembly required)

      Pick One from Column A, Two from Column B, etc.
      Emil W. Ciurczak, DoraMaxx Consulting 03.04.20

    • Coronavirus 2020

      Coronavirus 2020

      What’s The Impact To The World and Industry?
      Ben Locwin, Contributing Editor 03.04.20

    • Supply Chain
      What We Have is Failure to Communicate

      What We Have is Failure to Communicate

      When it comes to implementing track and trace technology, why is Pharma dragging its feet?
      Emil W. Ciurczak, DoraMaxx Consulting 01.28.20


    • Vision: 2020

      Vision: 2020

      You have exactly 366 days in 2020 to bring your clarity of vision to reality.
      Ben Locwin 01.28.20

    • Solid Dosage/Creams/Ointments
      The “Greening” of Solid Dosage Form Manufacturing

      The “Greening” of Solid Dosage Form Manufacturing

      Going “green” can mean saving big bucks for pharma manufacturers.
      Emil W. Ciurczak, DoraMaxx Consulting 11.20.19

    • When Life Gives You Lemons…Raise Your Drug Prices

      When Life Gives You Lemons…Raise Your Drug Prices

      The hidden effect of economic models on global drug supply and shortages.
      Ben Locwin 11.20.19

    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
    • Bone Therapeutics, Rigenerand Ink Cell Therapy Deal
    • NovaQuest Private Equity Acquires CoreRx
    • JS Bio and Etta Biotech Advancing Partnership
    • Intravacc Completes Project for Provention Bio’s Vax Candidate
    • Lonza to Exit Pharma Softgels and Liquid-Filled Hard Capsules
    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

    BGG Obtains U.S. Patent on AstaZine Natural Astaxanthin for Heart Function During Exercise
    Qualitas Health/iwi Raises $10 Million in Investment Round
    Aker BioMarine Expands Krill Portfolio with Novel Protein Hydrolysate
    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

    CHF Solutions Appoints CEO
    Freehand Partners with Imperial Medial Solutions
    Intersect ENT Announces CMS Approval of Coding Application for Sinus Implant
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Bone Therapeutics, Rigenerand Ink Cell Therapy Deal
    NovaQuest Private Equity Acquires CoreRx
    JS Bio and Etta Biotech Advancing Partnership
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Marino Belotti Presents New Website
    Essence Cosmetics Expands in the U.S.
    Sigma Beauty Launches 'Brush Care' Sets at Sephora
    Happi

    Latest Breaking News From Happi

    Mix:Bar Launches at Target
    Crystal Deodorant Unveils Magnesium-Enriched Sticks
    Euromonitor Reveals Top 10 Global Consumer Trends for 2021
    Ink World

    Latest Breaking News From Ink World

    Cowan Graphics Adds Fujifilm Inca OnsetX3 HS
    Packaging Printing Market Worth $433.4 Billion by 2025: MarketsandMarkets
    O-I Foundation Gifts $50k to Facilitate COVID-19 Vaccine Access
    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

    Honeywell Delivered 225 Million Masks in December
    Techtextil, Texprocess Postponed to 2022
    Super Strong Inks Survive Tough Environments
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Bioventus Appoints SVP of Operations
    DePuy Synthes Receives 510(k) FDA Clearance for VELYS Robotic-Assisted Solution
    OrthoPediatrics Expands Agent Network in Three European Countries
    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