The Veterinary Drug Approval Process and FDA Regulatory Oversight: 2-day In-Person Seminar

By: Mark Hughes, Consultant, Hughes Veterinary Consulting
Location :- The Westin Houston Downtown, TX | Thursday, December 5, 2019 | Friday, December 6, 2019

We need the below information to serve you better

Course Description:

The U.S. Food and Drug Administration’s Center for Veterinary Medicine or CVM is responsible for the approval of veterinary drug products intended for both family pets and food-producing animals. However, FDA does not regulate all products intended for animal use. Jurisdiction over animal products including licensed biologics such as vaccines is shared with a number of other federal agencies. For example, animal vaccines, animal disease diagnostic devices and some animal biologics are regulated by the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service or APHIS; and products such as flea and tick collars are regulated by the Environmental Protection Agency.

This seminar on veterinary medicine regulations will provide attendees with an understanding of FDA’s veterinary drug approval process. This two day interactive course will cover:

  • Premarket approval process
  • Various sections of a New Animal Drug Application
  • Strategies for navigating the FDA approval process

Learning Objectives:

Upon completing this course on veterinary medicine regulations participants will:

  • Understand how the U.S. Food and Drug Administration regulates veterinary drug product.
  • Understand how FDA’s Center for Veterinary Medicine is organized.
  • Discuss the process by which veterinary drug products are reviewed and approved.
  • Learn how to open an INAD File and request fee waivers.
  • Obtain a working knowledge of various sections included within an NADA.
  • Develop a deep understanding of what is needed to substantiate product characterization, target safety and effectiveness.
  • Gain general understanding of FDA’s rules governing chemistry, manufacturing and controls (CMC).
  • Understand the various components of an animal field study to support product approval.
  • Discuss the difference between FDA’s various user fees and fee waivers.
  • Identify the elements of an FDA compliant label.
  • Develop a corporate compliance strategy covering labeling, marketing and advertising.
  • Explore problem solving methods to mitigate regulatory enforcement risks.
  • Explain how jurisdiction is split between various Federal agencies in a certain cases.
  • Learn how animal feed, veterinary devices, OTC drug products and nutritional supplement are regulated in the U.S.

Who will Benefit:

This course is designed for people tasked with developing and maintaining an animal health company’s product portfolio and responsible for overseeing a company’s regulatory strategies. This includes individuals responsible for overseeing regulatory affairs, developing veterinary drug products, evaluating new technologies or applications, and those tasked with ensuring corporate compliance. Among others, this includes:

  • Personnel new to the Animal Health Industry
  • CRO professionals
  • Entrepreneurs looking to add value to their products
  • Regulatory professionals
  • Compliance professionals
  • U.S. Agents of Foreign Corporations
  • Document control specialists
  • Record retention specialists
  • Legal Professionals
  • Financial Advisors and Institutional Investors
  • Consultants, Inspectors and cGxP Experts

Course Outline

Day One (8:30 AM – 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Introduction to Veterinary Drug Approval process
    • FDA’s jurisdiction and Centers relevant to Animal Health
      • Center for Food Safety and Applied Nutrition (CFSAN)
      • Center for Drug Evaluation and Research (CDER)
      • Center for Biologics Evaluation and Research (CBER)
      • Center for Veterinary Medicine (CVM)
    • Specifics of CVM
    • Intro to the FD&CA, AMDUCA, ADAA, FDAMA, MUMS, and guidance documents(GFI)
      • Overview of FDCA and regulations
      • Drugs versus Biologics
      •  Introduction to FDA Guidance for Industry (GFI) and other online resources
  • Overview of Veterinary Drug Development (NADA Pioneer Drugs)
    • Discovery/Acquisition
      • Preliminary Patent Protection Concerns
    • Submissions
      • Open INAD File
        • Sponsor information
        • Responsible Official
        • Product description
        • Target species and proposed indication
      • Early Information
      • Phased review
      • NADA (8 sections)
        • 5 Major Technical Sections
          • Chemistry, Manufacturing and Controls (CMC)
          • Safety (target animal safety study)
          • Effectiveness (clinical field study)
          • Human Food Safety (human food safety studies for food-producing animals)
          • Environmental Impact (EA/CE)
      • 3 Minor Technical Sections
        • Label
        • Freedom of Information summary (FOI)
        • All Other Information (AOI)
      • Administrative NADA
    • Brief Description of cGxP (GMP, GLP, & GCP)
  • Approval Process: Chemistry, Manufacturing Controls, Environmental Impact & Managing Clinical Trials
    • CMC
      • API: name, structure, properties
      • API manufacturing
      • Clinical Trial material
      • Final Formulation
      • VMF/DMF
    • Target Animal Safety
      • Content and format
      • Final Study Reports
      • Monitoring and Reporting Adverse Drug Events
    • Human Food Safety
      • Analysis of Drug Residues
      • Toxicology
      • Residue Chemistry
      • Microbial Food Safety
      • Regulatory Method Relied Upon by Sponsor
    • Effectiveness
      • Dosage Characterization
      • Substantial evidence (e.g. dose confirmation and clinical field studies)
      • All other information related to effectiveness
      • Proposed effectiveness-related labeling
      • Effectiveness Guidance Documents
      • Laboratory studies can be used to provide effectiveness data
      • The 7 Major Phases of Animal Field Studies
        • Planning
        • Study Initiation
        • In-life Activities
        • Site close-out
        • Data management
        • Biostatistical analysis
        • Report writing and preparing raw data files
      • Data collection and study documentation
    • Environmental Impact
      • Categorical Exclusions
      • Environmental Assessments (EA)
      • Common EA Components
      • Environmental Impact Statements (EIS)
    • Labeling 21 CFR requirements
    • FOI
    • AOI
  • Day Two (8:30 AM – 4:30 PM)
    1. Overview of Generic Animal Drugs (JINAD)
      • Submissions
        • ANADA sections
          • CMC
          • Bioequivalence (Safety & Efficacy)
          • Human Food Safety
          • All others
    2. Minor Use Minor Species (MUMS)
      • Designation
      • Indexing
    3. Animal Drug User Fees and Related Fee Waivers
      • Veterinary Drug User Fees and Fee Reductions and Waivers
      • Animal Drug User Fee Act (ADUFA) – Applies to Innovators Only
      • Animal Generic Drug User Fee Act (AGDUFA) – Applies to Generic Manufacturers
      • Types of User Fees
        • Animal Drug Application and Supplement Fee
        • Animal Drug Product Fee
        • Animal Drug Establishment Fee
        • Animal Drug Sponsor Fee
      • Types of Fee Waivers and Reductions
      • Procedures, Timing and FDA Evaluation of Waivers or Reductions
    4. Introduction to FDA’s Regulation of Veterinary Feed, OTC Drugs, Supplements and Medical Devices
      • Animal Feed
        • GRAS – 21 CFR 582
        • Feed Labeling
        • AAFCO
        • Veterinary Feed Directive (VFD)
      • Veterinary OTC Drugs and Nutritional Supplements
        • Regulatory Agencies
        • CVM Compliance Policy - CPG 690.150 & CPG 690.100
      • Veterinary Medical Devices CPG 655.100
      • USDA’s Animal and Plant Health Inspection Service
        • Virus Serum Toxin Act
          • Animal vaccines
          • Animal biologics
          • Animal disease diagnostic devices
      • EPA
        • Flea & Tick Products
        • Insect Repellants such as Equine Fly Sprays
        • State Registrations
    6. Non-Approval-Related Considerations
      • Extra-Label Drug Use
      • Compounding
      • Noncompliance and Enforcement
        • FDA Enforcement Authority over Development, Manufacture, Marketing, and Distribution
          • FDA’s Office of Regulatory Affairs (ORA): Responsible for field activities, imports, inspections, and enforcement policy
          • Local, State, and Tribal governments
          • CVM’s Office of Surveillance and Compliance
        • Types of Enforcement Actions
      • Pharmacovigilance
      • Post-approval submissions
        • CMC
        • Safety
        • Efficacy

    Meet Your Instructors

    Mark Hughes
    Mark Hughes,
    Consultant, Hughes Veterinary Consulting

    Dr. Mark Hughes, DVM, MS, has over 11 years of experience in veterinary drug product development and over 20 years of experience in laboratory animal medicine, development of in-vitro diagnostic tests, and research in animal reproduction. He has managed or contributed to clinical studies and regulatory submissions on the safety and effectiveness of veterinary drugs (including stem cells) for therapeutic treatments related to dermatology, cardiology, endocrinology, oncology, osteoarthritis, and infectious diseases. Through his consulting business, Hughes Veterinary Consulting, he assists domestic and international biotech and pharmaceutical companies with the process of applying for regulatory approval of drug products for use in companion animals and livestock.


    Location :

    The Westin Houston Downtown
    1520 Texas Avenue,
    Houston, TX 77002, USA
    Tel: +1-713-228-1520

    December 5-6, 2019

    How to Reach

    General Driving Directions:

    Driving directions from George Bush Intercontinental Airport (IAH)
    • 2800 N Terminal Rd, Houston, TX 77032, USA. Get on I-69 from Will Clayton Pkwy.
    • Head north on John F Kennedy Blvd. Use the right 2 lanes to take the ramp to US-59.
    • Merge onto Jetero Blvd/Will Clayton Pkwy.
    • Continue to follow Will Clayton Pkwy. Pass by Waffle House (on the right in 3.6 mi).
    • Turn right onto 4th St/Eastex Freeway Service Rd.
    • Use the left lane to take the US 59 S/I-69 ramp.Merge onto I-69.
    • Follow I-69 to N Jackson St in Houston. Take the Jackson St exit from I-69.
    • Use the right 2 lanes to merge onto N Jackson St toward George E Brown Convention Center.
    • Take La Branch St to Texas St. Use the right lane to merge onto N Jackson St.
    • Turn right onto Commerce St. Turn left onto La Branch St. Turn left onto Texas St.
    • Destination will be on the right. The Westin Houston Downtown.
    Driving directions from William P Hobby Airport (HOU)
    • Exit the airport going north on Broadway Street.
    • Turn left onto Interstate 45 North.
    • Take Exit 47B and turn right onto Memorial Drive.
    • Continue onto Rusk Street.Turn left onto San Jacinto Street.
    • Turn right onto Texas Avenue.
    • The hotel will be on the right across from Minute Maid Park

    Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. GRC Seminars is not responsible for any inaccuracies in the same.
    Register Online

    Register Online


    Seminar One Registration

    December 5-6, 2019, Houston, TX
    (Registrations till November 15, 2019 - $1699)
    (Registrations after November 15, 2019 - $1899)

    The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both the days.

    The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both the days.
    For discounts on multiple registrations, contact customer care at +1-1-888-771-6965.

    Register by Wire Transfer

    If you wish to pay by wire transfer: Please call us at
    Toll Free +1-1-888-771-6965

    Download Registration Form

    Yes, I want to attend "The Veterinary Drug Approval Process and FDA Regulatory Oversight: 2-day In-Person Seminar"
    Click here to Download Registration Form
    If you are paying by check:
    Checks should be payable to MetricStream Inc. (our parent company). and mailed to:
    2479 East Bayshore Road, Suite 260
    Palo Alto, CA 94303

    Terms & Conditions to register for the Seminar/Conference/Event

    Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @


    Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

    Cancellations and Substitutions:

    Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

    On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future GRC Seminars event and a credit note will be issued.

    Substitutions may be made at any time. No-shows will be charged the full amount.

    We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

    In the event GRC Seminars cancels the seminar, GRC Seminars is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

    Attendance confirmation and Documents to carry to the seminar venue:

    After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

    Conference photograph / video:

    By registering and attending GRC Seminars conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by GRC Seminars for marketing, archiving or any other conference related activities. You agree to release GRC Seminars for any kind of claims arising out of copyright or privacy violations.

    Media Partners

    If you wish to partner with us for this event please contact us: or call us: +1-888-771-6965.
    Media Partner Benefits
    • Logo and company data on the event website.
    • Logo on the conference material distributed during the conference.
    • Media Partner’s brochure distributed along with conference material.
    • Logo on all the mailings before and after the event.
    • 10% discount to media partner's subscribers.
    Media Partner to do
    • Banner (min 728x90 or 468x60) on the Media Partner website.
    • Insertion of the event in the event calendar, both printed and/or online.
    • Announcement article of the conference on the Magazine and/or Website.
    • Dedicated email blast to all subscribers of Media Partner.
    • Article on the Magazine and/or Website after the conference.

    Local Attractions of Houston, TX

    Bayou Place
    TLocated in the heart of Houston's Downtown Theater District, this 130,000 square foot entertainment megaplex is comprised of theaters, bars, lounges, and restaurants. Start the evening off with dinner at the legendary Hard Rock Café or the authentic Italian trattoria, Mingalone. Enjoy box office hits or catch the latest indie flick at the Angelika Film Center followed by drinks and dancing at ROCBAR, Houston's largest rock and roll nightclub.

    Galleria Mall
    The Galleria Houston, Texas's largest mall, is an upscale shopping mall centrally located just outside the 610 loop in Houston's Uptown District. The retail center is anchored by Macy's, Neiman Marcus, Nordstrom and Saks Fifth Avenue, and occupies such high-end tenants as Tiffany and Co., Dior, Louis Vuitton, and Yves Saint Laurent.

    Johnson Space Center
    The Lyndon B. Johnson Space Center, home of the NASA astronaut corps, is located in Southeast Houston. The center spans 1,620 acres and consists of 100 facilities. Tourists can experience a simulation of a zero-gravity environment in the Living in Space exhibit or encounter a virtual rocket launch complete with exhaust at the Blast Off Theater.

    Houston Zoo
    Sheltering over 4,500 animals and 900 species, The Houston Zoo is the 7th most visited zoo in the nation. Spend the day strolling through the facility's beautifully landscaped grounds or enjoy a more hands-on encounter by scheduling a guided tour. Tour experiences range from feeding a lion cub to shadowing a staff veterinarian for an entire day.

    Museum Distric
    The Houston Museum District refers to the collection of museums, galleries, and cultural centers located within a 1.5 mile radius of Herman Park. The Museum of Fine Arts which also houses the Bayou Bend Collection and Gardens, boasts a collection of over 56,000 pieces.