Instead, the group said, the S.E.C. should accept modifications imposed by the European Commission.
Should any modifications of their views be left to evolve or not (see above) from internal debate — or be forced by legal or economic pressure?
Novartis is arguing that the term should encompass modifications that might make a drug safer or easier to use, not just more effective in treating a disease.
Thus, further feasibility studies should test modifications of the intervention and the study design.
Prior to the orders, the regulators had not had clear rules on how the banks should handle modification applications.
Therefore, to avoid residual confounding, case-crossover studies of environmental exposures should consider modification of temperature-asthma associations by temporal matching factors such as month or season.
25 Furthermore, all guidelines recognize that any comprehensive diabetes-care plan should include modification of other CVD risk factors and also provide recommendations to this effect.
Such data would represent an unprecedented resource to address important questions like when should treatment modification criteria be changed based on characteristics of the patient population.
Such modifications should, of course, be restricted to observation of the available data and should not be based on the results of preliminary analysis.
Such modifications should only be made following approval by the local safety committee and any modified equipment should always be re-validated before use.
