subject
Business, 12.08.2020 05:01 bsheepicornozj0gc

An investigator proposes to study a market approved product sold to treat high blood pressure in individuals over age 12. This study will look at using a liquid formulation for children under age 12. The drug sponsor hopes that the information from the research can be used to change the labeling for use of the drug in children. Which of the following is the investigator’s most appropriate course of action? A) Submit the research protocol to OHRP for their review
B) Submit the research protocol to the IRB, but do not submit an IND application to the FDA since the drug is already approved and marketed for this indication.
C) Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting research.
D) Submit an Investigational Device Exemption (IDE) application to the FDA.

ansver
Answers: 2

Another question on Business

question
Business, 21.06.2019 21:00
On june 1 of the current year, chad wilson established a business to manage rental property. he completed the following transactions during june: opened a business bank account with a deposit of $28,000 from personal funds. purchased office supplies on account, $2,690. received cash from fees earned for managing rental property, $7,390. paid rent on office and equipment for the month, $3,310. paid creditors on account, $1,230. billed customers for fees earned for managing rental property, $6,130. paid automobile expenses (including rental charges) for the month, $740, and miscellaneous expenses, $370. paid office salaries, $2,330. determined that the cost of supplies on hand was $1,590; therefore, the cost of supplies used was $1,100. withdrew cash for personal use, $2,210. required: 1. indicate the effect of each transaction and the balances after each transaction: for those boxes in which no entry is required, leave the box blank. for those boxes in which you must enter subtractive or negative numbers use a minus sign. (example: -300) answer
Answers: 1
question
Business, 21.06.2019 22:10
3. now assume that carnival booked lady antebellum in december 2016 to perform on the june 2017 western caribbean cruise. further assume that carnival pays lady antebellum its entire performance fee of $52,000 on december 28, 2016, for the june 2017 cruise. what journal entry will carnival make on december 28, 2016, for its payment to lady antebellum?
Answers: 1
question
Business, 21.06.2019 23:10
You are the new chief information officer for the video-game developer, necturus games. the company has recently undergone a major expansion of its primary product, and you must staff up the is department and determine the best way to develop new game "capsules" for the game, "escape velocity."
Answers: 1
question
Business, 22.06.2019 04:00
Wallis company manufactures only one product and uses a standard cost system. the company uses a predetermined plantwide overhead rate that relies on direct labor-hours as the allocation base. all of the company's manufacturing overhead costs are fixed—it does not incur any variable manufacturing overhead costs. the predetermined overhead rate is based on a cost formula that estimated $2,886,000 of fixed manufacturing overhead for an estimated allocation base of 288,600 direct labor-hours. wallis does not maintain any beginning or ending work in process inventory.
Answers: 2
You know the right answer?
An investigator proposes to study a market approved product sold to treat high blood pressure in ind...
Questions
question
Mathematics, 15.12.2021 18:00
question
Mathematics, 15.12.2021 18:00
Questions on the website: 13722367