The agency delayed the product once before, in April, seeking additional data.
Amylin Pharmaceuticals Inc. said yesterday that the Food and Drug Administration was seeking additional data on its experimental diabetes drug Smylin.
Rep. Smith sent two additional letters in September, seeking additional data and reiterating his desire for internal communications.
Company executives told analysts in a conference call Friday morning that Merck was delaying its application for the drug, odanacatib, because it is seeking additional data from a clinical trial.
Through an iterative series of participatory meetings, the partners reviewed the questions, provided responses, sought additional data for unanswered questions, and finally confirmed the responses on the completed instrument.
The data collection forms will seek additional information on risk factors in both cases and controls, and the management and outcome of the ICH.
Follow-up telephone calls were made to seek additional information.
Applicators completing this questionnaire were given additional take-home questionnaires, which sought additional information on occupational exposures (commercial and private applicator questionnaire data version P1REL0310.02 and cancer registry/mortality data version AHSREL0412.01 were used in this analysis).
Therefore, as an interim measure, one may choose to directly apply the rodent dose response relationship to humans and seek additional mechanistic or epidemiologic data to refine the human risk assessment.
According to the consent decree, Facebook does not need to seek additional permission to share friend data with service providers.
Last week Amylin said the U.S. Food and Drug Administration was seeking additional clinical data on Symlin.
