Navigation Links
PETA addresses USDA's TABST exemption policy plans
Date:8/15/2012

In public comments submitted yesterday, People for the Ethical Treatment of Animals (PETA) applauds the United States Department of Agriculture (USDA) Center for Veterinary Biologics (CVB) for announcing its plans to allow firms to secure exemptions from the target animal batch safety tests (TABST) that have until now been required for each batch of veterinary biologics products, including live and inactivated vaccines. In draft memorandum 453, USDA states that CVB intends to consider TABST exemptions in line with recommendations in the TABST waiver guideline drafted by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), in which USDA participates.

Under this new policy, CVB will consider exemption requests for products based on the submission of a report that includes an assessment of products' safety performance without the need for the generation of new data. Following an exemption from TABST, annual summary reports for adverse events related to exempted products will be required to maintain the exemption.

After studies conducted by the Advisory Group on Alternatives to Animal Testing in Immunobiologicals (AGAATI) determined that decades of advancement in vaccine manufacturing had rendered TABST irrelevant for routine product testing, AGAATI recommended the immediate deletion of TABST requirements from European Pharmacopoeia monographs. Since the publication of this recommendation, PETA has worked to ensure the elimination of all remaining barriers to exemption from TABST. At the request of PETA and PETA U.K., greater oversight of the exemption process and the removal of fees for exemptions vastly increased the implementation of TABST waivers.

Based on experiences in the U.K., PETA has requested that USDA take a stronger role in encouraging complete implementation of TABST exemptions. Although USDA's plans to allow manufacturers to apply for exemptions is progressing in advance of the VICH guideline's completion, the agency's draft memorandum 453 nevertheless imposes restrictions on the exemption process that do not appear in the VICH draft guideline and for which scientific support has not been provided. Specifically, USDA intends to disqualify products containing Gram negative antigens from eligibility for TABST exemptions. PETA has called upon USDA to consider these products for TABST exemptions when they are able to meet the standard of sufficient existing pharmacovigilance and serial release data required for all other eligible products.


'/>"/>

Contact: Jeffrey Brown
JeffreyB@peta.org
310-437-8003
People for the Ethical Treatment of Animals
Source:Eurekalert

Related medicine news :

1. AFARs MSTAR program addresses shortage of geriatric medicine physicians
2. Ethics should drive health policy reform, especially with physician-owned specialty hospitals
3. Radiologists rank themselves as less than competent on health policy issues
4. Internal medicine physician specialists release policy paper on reforming Medicaid
5. White House Drug Policy Shifts Strategy
6. Weill Cornell Medical College establishes Center for Healthcare Informatics and Policy
7. Medicare Beats Private Plans for Patient Satisfaction: Survey
8. Half of Americans with individual health plans could gain better coverage under the ACA
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/21/2020)... ... May 21, 2020 , ... In response ... be lifted on May 28th and all businesses will be required to have ... back to work. , As an essential business, AmeriCare Medical began this precautionary ...
(Date:5/21/2020)... ... May 21, 2020 , ... Casenet® LLC today ... that supports care management and utilization management at health insurance plans. Developed over ... 2020 provides significant usability and automation upgrades to all of its existing features, ...
(Date:5/17/2020)... ... 2020 , ... R3 Stem Cell International is now offering ... are two program options for patients and their families, which are all inclusive ... exactly what causes Autism Spectrum Disorder (ASD), there are several recent clinical studies ...
(Date:5/16/2020)... ... May 15, 2020 , ... KUDO ... with the Open Source Medical Supplies (OSMS). The organization will obtain free access ... reduce the spread of COVID-19. , Created as a response to the COVID-19 ...
(Date:5/15/2020)... ... 2020 , ... Collagen has taken the areas of beauty and anti-aging by ... to a 2020 Nutritional Outlook ‘Ingredients to Watch’ US forecast. Collagen ingredients have matured ... high molecular weight, low-impact products of the past to the clinically-studied, low-molecular weight hydrolysates ...
Breaking Medicine News(10 mins):
(Date:5/21/2020)... ... May 21, 2020 , ... Cataract is the world's leading cause ... all nations. In the United States, more than 25 million Americans are estimated to ... Costs of Vision Problems .” As the population in America continues to age, the ...
(Date:5/21/2020)... ... May 21, 2020 , ... Today Anyblock ... of the Corona SeroStatus app. Many facilities, cities, states/provinces, and countries are eager ... of coronavirus globally—including nearly 1.5 million in the United States alone—serious concerns remain ...
(Date:5/21/2020)... Ore. (PRWEB) , ... May ... ... May 2020 , Guests: Kevin Kearns, Boston, Massachusetts, founder/CEO of Burn with ... IDEA, the world’s largest association for fitness and wellness professional & competitive ...
Breaking Medicine Technology: