Veterinary Drug Approval Process | FDA’s Center for Veterinary Medicine (CVM) Regulations

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The U.S. Food and Drug Administration’s Center for Veterinary Medicine (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

Seminar Fee Includes:

Lunch

AM-PM Tea/Coffee

Seminar Material

USB with seminar presentation

Hard copy of presentation

Attendance Certificate

$100 Gift Cert for next seminar

Download Brochure

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

Day 01(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 02(8:30 AM - 4:30 PM)

Overview of Generic Animal Drugs (JINAD)
- Submissions
  - ANADA sections
    - CMC
    - Bioequivalence (Safety & Efficacy)
    - Human Food Safety
    - All others
Minor Use Minor Species (MUMS)
- Designation
- Indexing
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
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 (CVB, APHIS, FSIS) & EPA
- 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
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

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.

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Seminar One Registration

December 5-6, 2019, Houston, TX

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Online using Credit card

$1,699.00

Seminar One Registration

March 5-6, 2020, Orlando, FL
(Registrations till December 15, 2019 - $1699)
(Registrations after December 15, 2019 - $1899)

Your registration fee includes the workshop, all course materials and lunch.

For discounts on multiple registrations, contact customer care at +1-888-717-2436.

Other Registration Option

By order form / PO#

Download the Order Form
Fill this form with attendee details & payment details
Fax it to +1-650-362-2367, or
Email it to customercare@complianceonline.com

Payment Mode

By Check -

Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 E. Bayshore Road Suite 260
Palo Alto, CA 94303
USA

By Wire -

Please contact us at +1-888-717-2436 to get details of wire transfer option.

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

Early bird seats are limited and based on first-come, first-serve.

Multiple offers cannot be combined.

Houston, TX
December 5-6, 2019

Hotel

The Westin Houston Downtown
1520 Texas Avenue,
Houston, TX 77002, USA

Tel: +1-713-228-1520

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. ComplianceOnline is not responsible for any inaccuracies in the same.

Orlando, FL
March 5-6, 2020
(Venue to be announced shortly)

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Logo on website, marketing email, branding materials & the registration booth
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Media Partner:

Pharmaceutical-Tech is essentially a B2B online business, technology media platform and global magazine that have under its wraps the largest global database of Pharmacy buyers and suppliers. We cover in-depth trends that shape industry dynamics and metamorphose global economics. Pharmaceutical tech has created a recognition that spans over a global audience, thereby revolutionizing how businesses transact.

Local Attractions of Houston, TX

Bayou Place

Located 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. The mall is also home to two separate Westin hotels.

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 District

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. Just a few blocks away is the John P. McGovern Health Museum which is home to Houston's first and only 4D theater. Other area attractions include the Holocaust Museum, Houston Center for Photography, and the Lawndale Art Center.

Local Attractions of Orlando, FL

Walt Disney World Resort

This massive, world-famous theme park includes Magic Kingdom Park, Disney - MGM Studios, Epcot, Disney's Animal Kingdom, Downtown Disney, and more.

Magic Kingdom Park

Opened in October of 1971. One of the most famous theme parks in the world featuring Cinderella's castle with classic rides like Pirates of the Caribbean, Haunted Mansion, Space Mountain, Country Bear Jamboree, Hall of Presidents, etc. Frontierland, Tomorrowland, Liberty Square, Adventureland, and Fantasyland, Great for families with kids 10 and younger.

Universal Studios Orlando

Theme studios park features Jaws, T2, Twister, Men In Black, etc. and various back lot sets used in the movies. CityWalk is an entertainment venue with many restaurants, night clubs, retails stores and a great party atmosphere. Movie theatre near the entrance. Also Hard Rock Cafe, Jimmy Buffet's Margaritaville, Emiril's, NASCAR Cafe.

Discovery Cove

Get close to nature with everything from a coral reef and tropical river swim to an aviary and sting ray lagoon at Discovery Cove, a park that's part sanctuary, part adventure.