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:4/29/2016)... ... 29, 2016 , ... Coalition Duchenne, a Newport Beach, California ... Duchenne research, participated in the April 25 U.S. Food and Drug Administration advisory ... The meeting at the Marriott Conference Center in Hyattsville, Maryland was attended by ...
(Date:4/29/2016)... ... ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh in Abilene, Texas, ... is time to set the record straight. Traditionally, BC and AD has been referred ... true and offers explanation. , “To start with, the Name of the Savior has ...
(Date:4/28/2016)... St. Petersburg, FL (PRWEB) , ... April 29, 2016 , ... Sublime Beauty® is offering ... of the same product) for 50% off. The discount is applied to the product with ... box is given to those who purchase $250 or more in products. , "So many ...
(Date:4/28/2016)... (PRWEB) , ... April 28, 2016 , ... ... accessories, is proud to partner with AquaShieldUSA, the country's oldest waterproof cast ... clinic and medical supply stores, the largest selection of daily, night, weatherproof and ...
(Date:4/28/2016)... (PRWEB) , ... April 28, 2016 , ... Cosmetic Town, ... website, cosmetictown.com . The forum section was recently revamped and upgraded to allow ... surgical techniques in use across the country. , According to the senior editor of ...
Breaking Medicine News(10 mins):
(Date:4/29/2016)... 2016 Automation is one of ... to the growing demands for productivity in speed, accuracy, ... systems are already adept of a wide range of ... manual labor. Instrumentation continues to evolve, and is poised ... a few years ago. Originally used mostly by the ...
(Date:4/28/2016)... , April 28, 2016 ... George Phillips und Stephen ...    ArisGlobal®, ein führender Anbieter ... gab heute bekannt, dass neue Führungskräfte zum ... gestoßen sind, die vielfältige Erfahrungen mitbringen.  Dies ...
(Date:4/28/2016)... Oramed Pharmaceuticals Inc. (NASDAQ: ORMP ) ... development of oral drug delivery systems, announced today that the ... by Joseph Gunnar & Co. LLC, taking place ... . Nadav Kidron , CEO of Oramed, will present ... Details:   PIONEERS 2016, presented by Joseph ...
Breaking Medicine Technology: