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For example, from Taxol's approval letter: Phase 4 study for info. on the metabolic fate of taxol in humans, the characterizing of the active metabolite and the mass balance of the drug.
Or from the rotavirus vaccine:
We acknowledge the postmarketing clinical commitments outlined in your submissions to the BLA as follows:
1. Your submission dated January 25, 2006, included a commitment to conduct a large-scale observational post-licensure safety study to evaluate the incidence of intussusception and other safety parameters in recipients of Rotateq in approximately 44,000 subjects (adjustments to the sample size will be made based on the background rate of intussusception). The study will be designed to detect an increased risk of intussusception due to vaccine of 2.5 or greater with 80% probability. The final study protocol will be submitted by May 5, 2006. The study will be initiated no later than the third quarter of 2006, sooner if possible. The study will be completed by the fourth quarter of 2008.
Or one from a tetanus vaccine:
Postmarketing Studies subject to reporting requirements of 21 CFR 601.70.
1. You have agreed to conduct a safety and immunogenicity postmarketing study in approximately 3000 subjects receiving your Tetanus and Diphtheria Toxoids Adsorbed For Adult Use vaccine under IND, to include a subset of subjects 60 years of age and older. You have agreed to submit a final study protocol by December 2003, and to initiate this study by April 2004 or 2 weeks after CBER releases the first commercial batch of Tetanus and Diphtheria Toxoids Adsorbed For Adult Use, whichever is later. In addition, you have agreed to complete patient accrual 20 months after the first patient is enrolled in the study and to complete the study 6 months after the last patient has been enrolled in the study. The final study report will be submitted 1 year after the last patient has completed the study.
Or one from the varicella vaccine:
Your commitment to perform post-licensure studies over at least a 15 year period, following the outline in your submission to the Product License Application dated August 19, 1994, with modifications specified in submissions of February 24, 1995, and March 10, 1995 is acknowledged to be an integral part of the basis for approval. It is understood that Merck will provide CBER with copies of the appropriate protocols, and CBER will have the opportunity to comment on these protocols prior to initiation of any studies. It is further understood that Merck will provide CBER with annual reports on the progress of these studies. These commitments have been made a part of your Product License Application for this product.
It is requested that adverse experience reports for Varicella Virus Vaccine Live be submitted in accordance with the adverse experience reporting requirements for licensed biological products (21 CFR 600.80) and that distribution reports be submitted as described (21 CFR 600.81). Since your product is categorized as a vaccine, it is our recommendation that these reports be submitted to the Vaccine Adverse Event Reporting System (VAERS) using the pre-addressed form VAERS-1. The toll-free number for VAERS forms and information is 800-822-7967.
Or one from the pneumococcal vaccine:
We acknowledge your commitments dated November 2, 1999, December 10, 1999, and February 14, 2000, for the following manufacturing issue, as well as Phase 4 clinical studies and data:
1. You have agreed to establish alert and action limits for the amount of residual <____________________________________> in the final polysaccharides. The data justifying alert and action limits will be submitted to CBER by the 1st Quarter of 2001.
2. You have agreed to obtain additional safety data for previously unvaccinated children who receive Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) according to recommendations for "catch-up" immunization. A study(s) will evaluate reactogenicity of vaccination for the age groups 7 months to less than 2 years, 2 years to less than 5 years, and 5 years to <___> years. This study will be initiated in April 2000.
3. You have agreed to initiate a Phase 4 study to evaluate less common adverse events in <_______> children who will receive <____> doses of Pneumococcal 7-valent Conjugate Vaccine (Diphtheria cRM197 Protein) concomitantly with routinely recommended childhood vaccines, e.g., DTaP, Haemophilus influenzae type b conjugate vaccine, IPV and hepatitis B vaccine. This study will be initiated in April 2000.
4. You have agreed to evaluate the safety and immunogenicity of concomitantly administered vaccines, e.g., DTaP, Haemophilus influenzae type b conjugate vaccine, MMR and varicella vaccines, with a fourth dose of Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) in 12-15-month old children who previously received three doses of DTaP, IPV, Haemophllus lnfluenzae type b conjugate vaccine and Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRMl97 Protein). This study will be initiated in January 2001 as subjects in the Phase 4 safety study reach 12-15 months of age.
5. You have agreed to continue surveiilance for invasive pneumococcal disease in children who received Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) in the efficacy study conducted at Northern California Kaiser Permanente.
6. You have agreed to provide comparative immunogenicity data for pertussis, Haemophilus influenzae type b (Hib) and poliovirus responses for children who received DTaP, Hib, IPV and Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) during the primary immunization series. We acknowledge your commitment to provide these data from a study performed in <_________> These data will be submitted to CBER in April 2000.
7. You have agreed to provide safety and immunogenicity data for Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRMl97 Protein) administered to high-risk children, e.g., HIV-infected infants, subjects with sickle cell disease and bone marrow transplant recipients.
Or from the meningitis vaccine:
Postmarketing Studies subject to reporting requirements of 21 CFR 601.70.
3. To conduct an open label, descriptive, epidemiological, safety surveillance study that enrolls 20,000 subjects or enrolls for 1 year, whichever results in the larger enrollment. The study protocol will be submitted by May 2005. The study will be initiated by July 2005. The final study report will be submitted 1 year after the last subject has completed the study, July 2008.
4. To conduct a randomized, modified double-blind, comparative study evaluating safety and immunogenicity when Menactra vaccine is given concomitantly with Tetanus and Reduced Diphtheria and Acellular Pertussis Vaccine, Adsorbed (Tdap). The study will be conducted in approximately 1400 adolescents aged 11-17 years. The study protocol will be submitted by March 2005. The study will be initiated by April 2005. The final study report will be submitted by December 2006.
5. To conduct an open label study that enrolls approximately 400 participants to evaluate the duration of the antibody response in participants who had received a single dose of Menactra vaccine or Menomune vaccine 5 and 10 years earlier. Enrollees will be between 16 and 23 years of age when they are 5 years post vaccination. The study protocol will be submitted by September 2005 with study initiation for the 5 year follow up by November 2005. Study initiation for the 10 year follow up is planned by November 2010. The clinical study reports will be submitted as two reports, one report will be submitted for the 5 year follow up study and one report will be submitted for the 10 year follow up. The first report will be submitted 1 year after the last patient has completed the 5 year follow up, May 2007, and the second report will be submitted 1 year after the last patient has completed the 10 year follow up, May 2012.
6. To conduct a multi-center, modified double blind, active controlled clinical study to evaluate the safety and immunogenicity of Menactra vaccine in subjects greater than 55 years of age. The study protocol will be submitted by October 2005 and the study initiated by January 2006. The final study report will be submitted by January 2008.
Do I have to continue or do you get that this is not out of the ordinary?
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