The project received ethical clearance as a prerequisite of approval for funding from the Italian Ministry of Health, according to the Italian Ministry of Health law number (ex art. 12bis D.lgs 229/99).
Whilst understanding mechanism of action (MOA) is not a prerequisite for FDA approval, it can guide a medicinal chemistry effort, predict potential toxicities and help define patient populations for clinical trials and ultimately the market place.
Since 2013, trial registration is required as a prerequisite for ethical approval in the UK [ 66, 67].
Sterility, or low bioburden, is likely to be a prerequisite for regulatory approval, while MN arrays must be capable of being produced in a range of sizes to suit required drug doses.
The second suggestion of private sector representatives of the ecotoxicological approach is that field tests should not be a prerequisite for GMO approvals, but should only be demanded when literature studies or ecotoxicological experiments show significant negative effects [44].
The paper gives an overview of the international activities in the area of harmonisation of nuclear safety requirements, as a prerequisite for the potential approval of standard nuclear power plant designs in more than one country.
For the reduction of GG molecular weight, the probe sonication approach was used because in such case no chemicals are needed, and such aspect represents an important prerequisite for the marketing approval of the obtained polymer.
Prime Minister Jan Peter Balkenende, visibly perturbed, went on national television to announce that his cabinet would not submit the couple's marriage to Parliament for its approval, a prerequisite for succession to the throne.
Disillusioned voters have assumed that Syrian approval was a prerequisite for getting elected.
But only two genetically modified seeds (MON810 and the Amflora potato seed) out of dozens on the global market have made it through the European Commission's laborious approval process, a prerequisite for use.
The Structural Funds Regulation - decided unanimously last year by all the Member States - clearly states that the ex-ante evaluation is a prerequisite to the programme and the planning documents which the Member States submit to the Commission for approval.
