Critics have claimed a number of issues with the<unk>  program. First, the<unk>  voucher might be too small or too large to encourage drug development. It may be too small because tropical diseases with incredible burdens can be presumed to merit more resources. This is likely not the case for pediatric rare diseases, some drugs are developed for pediatric use through expansion of adult drug research for similar conditions. The<unk>  voucher might be too large, if it rewards research which would have been done anyway, or research with low value. The<unk>  voucher may tax FDA resources. To mitigate this, use of the<unk>  voucher includes an extra fee paid by manufacturers to the FDA and requires that voucher bearers provide FDA with 90 days' notice before using a voucher. Critics of the FDA allege that<unk>  might not be safe.<unk>  should not, however, be confused with accelerated approval or fast track designation.<unk>  does not omit safety or efficacy studies or require approval within a given time frame. It sets a target of 6 rather than 10 months for FDA<unk> . Nevertheless, a study in 2008 claimed that new molecular entities approved in the two months before the first<unk>  deadlines showed a higher rate of postmarketing safety problems than drugs approved at other times. Nardinelli and colleagues (2008) of the FDA, however, wrote that they were not able to replicate the findings and that the findings might be driven by HIV-AIDS therapies. Following the Nardinelli piece, Carpenter acknowledged several errors in their data set and demonstrated errors in the FDA's and Nardinelli's data; Carpenter and colleagues report that the original associations between last-minute approvals and safety problems hold. There have also been complaints that the<unk>  voucher encourages innovation, but does not pay for access to existing therapies. Funding from governments or foundations might be needed to purchase treatments for poor people. Aidan Hollis of the University of Calgary has commented that the proposal does not address "the access problem, but helps to increase incentives through creating distortions in markets in developed countries". This is entirely a separate issue from the promotion of research intended by the<unk>  program.
Priority review
Clinical peer review
Risk assessment
Prescription monitoring program
Significant event audit
Rapid reviews
Outbreak response
Incident report