CVM Moving to Zoom; Practice Sessions Scheduled
The government has decided to discontinue WebEx for virtual meetings and has rolled out Zoom.gov The Division of Generic Animal Drugs (DGAD) will be hosting two Zoom practice session events for industry sponsors to experiment with the new platform in advance of using it for a pre-submission conferences or other formal meetings. Features like video cameras, sharing screens, using the chat, and muting and unmuting features will be demonstrated. Please note CVM will not be fielding questions about the generic drug review process or other pre-approval questions during these events, which are strictly for demonstrating the Zoom platform.
Sponsors (and as many of their representatives as desired) may attend one or both sessions which will have the same agenda and each cover the same demonstration. RSVP to CVMDGADMGT@fda.hhs.gov by Friday April 2, 2021, to let CVM know who will be attending from your company so that we can get an estimated head count. In your RSVP please include the names of all attendees, the sponsor name, and the date (or dates) that you plan to attend.
DEMO #1: April 15 @ 1:30pm EST
DEMO #2: April 29 @ 2:30pm EST
Vet API Workshop at USP: Updated Agenda Available
June 7, 2018
Programming for the USP Workshop, July 18-19 in Rockville, MD now includes confirmed presentations by experts from USP, FDA-CVM, and industry and Q&A Panels. The Workshop is a must-attend for API manufacturers, suppliers, and animal drug sponsors with regulatory responsibilities. In-person and virtual attendance by WebEx are available. Registration and hotel information may be found here.
GADA to Co-Sponsor Vet API Workshop at USP
January 2, 2018
Uninterrupted availability of veterinary APIs to the pharmaceutical industry is critical. As regulatory and Pharmacopeial standards evolve, issues may arise resulting in Import Alerts, supply chain interruptions and drug shortages. This workshop, April 18-19, 2018 at USP in Rockville, MD, is open to the public and is designed to help understand the issues that arise between Industry and regulatory bodies pertaining to APIs and VMPs to better facilitate processes and provide solutions. The workshop will bring Industry and regulators together in an interactive environment with presentations and panel discussions covering all aspects of Veterinary Active Pharmaceutical Ingredients. For more information, click here.
GADA and CVM Present Antimicrobial Sales & Distribution Reporting Training
October 26, 2016
GADA will host a virtual training session on Wednesday, November 2, provided by CVM and presented by Sue Dessai of HFV 212 - Division of Surveillance, to assist members in new reporting requirements for sales and distribution of antimicrobial animal drugs. The objectives of the training session are:
The session begins at 12:00 Noon (Eastern), and is expected to be approximately 1.5 hours. There is no registration fee; all GADA member representatives are welcome to participate. For training login information please contact GADA at firstname.lastname@example.org
GADA Announces New Chair
August 3, 2016
Bill Zollers, Vice President of Regulatory Affairs - North America for Norbrook, Inc. has been appointed Chair for the Generic Animal Drug Alliance. Bill will fulfill the unexpired term vacated by former Chair Jennifer Johansson who recently resigned following her departure from Putney, Inc. Bill, as Chair of GADA, will represent GADA as Co-Leader (with Doug Rupp, GADA Vice Chair) of the AGDUFA III Negotiations Team and will fulfill all of the duties of the Chair as described in the GADA bylaws. Bill formerly served as both Vice Chair, and as Secretary, for GADA and brings a wealth of knowledge and experience to the role.
GADA Applauds FTC Effort to Ensure Veterinarian and Pet Owner Access to Generic Animal Drugs
July 8, 2015
The Generic Animal Drug Alliance (GADA), an independent professional trade organization representing generic animal health industry interests, says that FTC staff comments in their recent report entitled "Competition in the Pet Medications Industry" indicate that pet owners would benefit from increased access to veterinary generic drugs. Furthermore, the FTC report encourages veterinary drug industry stakeholders to continue to inform the FTC about exclusive dealing practices designed to restrict the large national distributors that serve 75% of the veterinarians in the United States from accessing veterinary generics.
GADA Chair, Jennifer Spokes Johansson, says the FTC was spurred to investigate manufacturer distribution policies and practices in the pet medications industry on behalf of U. S. pet owners who spent approximately $7.6 billion on prescription and OTC pet medications in 2013. "We believe that pioneer drug company restrictions on distributors' ability to carry generic animal drugs harm both veterinarians and pet owners, as both groups would benefit from increased access to FDA approved veterinary generics, and we encourage the FTC to take further action against such practices" says Johansson.
GADA Chair to Speak at Animal Health Forum
July 7, 2015
Jennifer Spokes Johansson, GADA Chair and Senior VP, Regulatory Policy and Counsel for Putney, Inc. will be presenting at the Legal, Regulatory and Compliance Forum on Animal Health and Veterinary Drugs and Therapeutics, September 10-11, 2015 at The Carlton Hotel, New York, NY. Johansson will present as part of a panel session entitled "Animal Medicines – The Approval Process" and will focus her remarks on the process for FDA approval of generic animal drugs. Other session will focus on legislative, political and grassroots initiatives impacting the animal health industry and issues such as drug compounding, advertising and promotion practices, adverse event reporting and animal feeds.
Registration discounts to attend this industry event are available to GADA Member representatives. For more information, click here.
GADA Welcomes Two New Members
June 17, 2015
GADA recently welcomed new Regular (ANADA Sponsor) Members. Lucid Pharma, LLC based in East Brunswick, NJ, currently markets a range of human cross-over products and has plans to develop, manufacture and distribute a range of veterinary generic formulations including some new to market products including orals and injectibles. Perrigo Animal Health, a business unit of Perrigo, hold ANADAs sponsored under legacy company Sergeant's Pet Care Products Company, formerly ConAgra and has plans to develop new generic animal drugs. Visit the GADA website's Member listing for more information about GADA Members.
FDA Publishes Draft Guidance for Compounding
May 19, 2015
FDA has released a draft Guidance for Industry #230 on compounding animal drugs from bulk drug substances by state-licensed pharmacies, licensed veterinarians, and facilities that register with FDA as outsourcing facilities under section 503B of the Federal FD&C Act. Also published is FDA's intention to develop a list of bulk drug substances in accordance with GFI#230. Click here for more information.
FDA to Hold Public Meeting on Alternative In Vitro Bioequivalence Pathways
March 17, 2015
On April 16, 2015, the FDA will sponsor a public meeting to discuss the use of in vitro methods as a mechanism for assessing the in vivo product BE of non-systemically absorbed (locally acting) drug products intended for use in veterinary species. The meeting will be held at 7519 Standish Place, Rockville, Maryland.
Given the imprecision and logistic challenges associated with clinical endpoint BE studies, the FDA is exploring alternative pathways that can be applied to ensure the equivalence of product performance and quality for those products that are non-systemically absorbed. Examples of the kinds of products where in vitro bioequivalence concepts can potentially be applied include some orally administered products (e.g., Type A medicated articles), solutions, emulsions, ointments, creams, suspensions, transdermal products, and intra-mammary formulations.
The FDA is seeking public input on current agency BE regulations and the possibility of adopting novel in vitro BE approaches based on in vitro release tests and product physico-chemical characterization. There will be opportunities for the speakers to respond to questions from the public as well an opportunity for participants to provide formal public comments. The agency encourages the public to submit comments and questions to the docket prior to the meeting.
Early registration is recommended because seating is limited. Attendees may register, ask general questions about the meeting, request an opportunity to make an oral presentation, or request special accommodations due to a disability by contacting Aleta Sindelar, CVM, FDA; 7519 Standish Place, Room 144, Rockville, MD 20855, 240-276-9230; Fax 240-276-9241; email address BioequivalencePublicMeetingRegistration@fda.hhs.gov.
GADA Welcomes Two New Members
February 18, 2015
GADA recently welcomed new Regular (ANADA Sponsor) Members. Quo Vademus LLC of Kenansville, NC is a distributor and sponsor of ANADAS for veterinary water soluble medications. e5 Pharma, LLC is a developer, manufacturer and distributor of animal health products located in Boca Raton, FL. Visit the GADA website's Member listing for more information about GADA Members.
GADA Elects Officers, Subgroup Chairs at 2014 Annual Meeting
GADA members met in Kansas City for the 2014 Annual Member Meeting during which elections for Officers and Subgroup Chairs were held, and goals and objectives for 2015 were established. Jennifer Spokes Johansson, J.D., Senior Vice President, Regulatory Policy and Counsel for GADA Member Putney, Inc., Portland, ME was elected Chair for the Alliance, for a three year term. Also elected for three-year terms were Stephanie Batliner, Director, Generics, Health & Wellness, Animal Health for Bayer HealthCare LLC, St. Joseph, MO, as GADA Vice Chair; Dr. Herschel J. Gaddy, Ph.D., President of Herschel J. Gaddy & Associates, St. Joseph, MO, as GADA Treasurer; and Douglas Rupp, VP Regulatory Affairs & Operations for Pharmgate, Omaha, NE, as GADA Secretary.
GADA's members also confirmed the 2015 Subgroups and Chairs, as follows: