The difference in time between a standard approval (12 months) and a priority review (6 months) could be worth as much as $300 million to a company depending on the sales potential of the product receiving the priority review.
NIFDC also developed a national EV71 vaccine antigen reference standard and neutralizing antibody standards (Approval No: 20100023, 0024).
Any standards approval must be based on membership approval of more than a simple majority.
What's not running as fast as the marketing is the technology development and the standards approval.
The National Institutes for Food and Drug Control NIFDCC) has established the first batch of Vero cell DNA reference standards (Approval No: 2011-NRS0044).
(g Part 19 of this chapter sets forth requirements and regulatory provisions applicable to licensees, holders of a standard design approval, applicants for a license, standard design certification, or standard design approval, and contractors or subcontractors of a Commission licensee, or holder of a standard design approval, and are in addition to the requirements in this section.
(ii) Constitutes a violation of a requirement, procedure, instruction, contract, purchase order, or policy of a licensee, holder of a standard design approval, applicant for a license, standard design certification, or standard design approval, or contractor, or subcontractor.
(1) Each licensee, each holder of a standard design approval, and each applicant for a license, standard design certification, or standard design approval, shall prominently post the revision of NRC Form 3, "Notice to Employees," referenced in 10 CFR 19.11 e).
Site parameters are specified in a standard design approval, standard design certification, or manufacturing license.
Design characteristics are specified in a standard design approval, a standard design certification, a combined license application, or a manufacturing license.
(3) Imposition of a civil penalty on the licensee, holder of a standard design approval, or applicant (including an applicant for a standard design certification under this part following Commission adoption of final design certification rule) or a contractor or subcontractor of the licensee, holder of a standard design approval, or applicant.
