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:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... advisory services for healthcare compliance program management, will showcase a range of technology ... Association for Assisted Living (NCAL) Convention and Expo to be held October 14–18, ...
(Date:10/12/2017)... Orleans, LA (PRWEB) , ... October 12, 2017 , ... ... centers in the U.S., announced today its plans to open a flagship location in ... will occupy the former Rooms To Go store next to Office Depot in the ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... IsoComforter, Inc. ... products, announced today the introduction of an innovative new design of the shoulder pad. ... so you get maximum comfort while controlling your pain while using cold therapy. By ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... has recently contributed a medical article to the newly revamped Cosmetic Town ... article spotlights the hair transplant procedure known as Follicular Unit Extraction ...
Breaking Medicine News(10 mins):
(Date:9/25/2017)... , Sept. 25, 2017  EpiVax, Inc., ... vaccine design, and immune-engineering today announced the launch ... the development of personalized therapeutic cancer vaccines. EpiVax ... provided exclusive access to enabling technologies to the ... MBA will lead EpiVax Oncology as Chief Executive ...
(Date:9/22/2017)... -- As the latest Obamacare repeal effort moves is debated, ... and Lindsey Graham (R-SC) medical device market ... is in an odd place.  The industry wants repeal ... on medical device sales passed along with the Affordable ... visits and hospital customers with the funding to invest ...
(Date:9/19/2017)... HistoSonics, Inc., a venture-backed medical device company developing a non-invasive, robotically assisted, platform ... leadership team developments today:   ... ... Tom Tefft ... Veteran medical device executive Josh Stopek , PhD, who has led ...
Breaking Medicine Technology: