subject
Business, 19.10.2019 12:30 jnsoccerboy3121

When the sponsor-investigator holds the ind for an investigational drug he or she is responsible for annual reporting of which one of the following to fda?

a) adverse event summary report, but only from unblinded portions of studies ("open-label ind safety report")
b) marketing plan (i. e. annual updated projection of sales and profits)
c) ind report
d) ind renewal application

ansver
Answers: 3

Another question on Business

question
Business, 22.06.2019 05:30
The hartman family is saving $400 monthly for ronald's college education. the family anticipates they will need to contribute $20,000 towards his first year of college, which is in 4 years .which best explain s whether the family will have enough money in 4 years ?
Answers: 1
question
Business, 22.06.2019 08:00
Suppose that xtel currently is selling at $40 per share. you buy 500 shares using $15,000 of your own money, borrowing the remainder of the purchase price from your broker. the rate on the margin loan is 8%. a. what is the percentage increase in the net worth of your brokerage account if the price of xtel immediately changes to (a) $44; (b) $40; (c) $36? (leave no cells blank - be certain to enter "0" wherever required. negative values should be indicated by a minus sign. round your answers to 2 decimal places.) b. if the maintenance margin is 25%, how low can xtel’s price fall before you get a margin call? (round your answer to 2 decimal places.) c. how would your answer to requirement 2 would change if you had financed the initial purchase with only $10,000 of your own money? (round your answer to 2 decimal places.) d. what is the rate of return on your margined position (assuming again that you invest $15,000 of your own money) if xtel is selling after one year at (a) $44; (b) $40; (c) $36? (negative values should be indicated by a minus sign. round your answers to 2 decimal places.) e. continue to assume that a year has passed. how low can xtel’s price fall before you get a margin call? (round your answer to 2 decimal places.)
Answers: 1
question
Business, 22.06.2019 18:00
David paid $975,000 for two beachfront lots in coastal south carolina, with the intention of building residential homes on each. two years later, the south carolina legislature passed the beachfront management act, barring any further development of the coast, including david's lots. when david files a complaint to seek compensation for his property, south carolina refuses, pointing to a passage in david's own complaint that states "the beachfront management act [was] properly and validly designed to south carolina's " is south carolina required to compensate david under the takings clause?
Answers: 1
question
Business, 22.06.2019 19:40
Chang corp. has $375,000 of assets, and it uses only common equity capital (zero debt). its sales for the last year were $595,000, and its net income was $25,000. stockholders recently voted in a new management team that has promised to lower costs and get the return on equity up to 15.0%. what profit margin would the firm need in order to achieve the 15% roe, holding everything else constant? a. 9.45%b. 9.93%c. 10.42%d. 10.94%e. 11.49%
Answers: 2
You know the right answer?
When the sponsor-investigator holds the ind for an investigational drug he or she is responsible for...
Questions
Questions on the website: 13722367