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Among the incentives provided by orphan designations, protocol assistance and scientific advice from regulatory bodies play a key role in guiding the conduct of studies to address the benefit/risk analysis for marketing authorization and approval [32, 33].
Policies related to the development of therapies have led funders to mandate Orphan Drug Designation and Protocol Assistance by regulatory agencies for some of their programmes ear-marked to support clinical trials in rare diseases.
Seven (22.6%) had received some form of protocol assistance or scientific advice from the EMEA.
Although 80 procedures for protocol assistance had been completed by April 2005 [ 15], we found that only 4 of the products that were approved in that period had obtained scientific advice or protocol assistance from the EMEA.
The EMEA has addressed this issue by offering protocol assistance and scientific advice to sponsors of designated orphan drugs.
Furthermore, of the 31 products authorised by October 2006, only 7 (22.6%) received protocol assistance or scientific advice.
Similar(51)
The responsibilities of the lab coordinator will also include administrative duties such as record keeping, website maintenance, preparation of IRB protocols, assistance with grant writing, reimbursement paperwork, scheduling, and related tasks around the lab.
Their positions are dedicated 100% to PI inquiries, protocol development assistance and training.
CG and EP developed the protocol with assistance from AO, collected and analyzed the data.
EOH and HBF designed the trial protocol with assistance from EMR and RAB.
We wish to thank the following: Dr. Elizabeth Gould for immunohistology protocols and assistance with confocal microscopy.
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