Iroko Project

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This document summarizes the anticipated scope of FDA’s activities beginning on October 1, 2013, and continuing until the date of enactment of an FY 2014 appropriation or Continuing Resolution for FDA (the “lapse period”). Please note that FDA’s anticipated activities are subject to resource constraints on the Agency due to the lapse in appropriations and may change in the event of a protracted lapse period.

Overview
During the lapse period, FDA activities related to medical products generally will be limited to the following:
Excepted work involving the safety of human life or the protection of property, including Criminal law enforcement work; and
Activities funded by carryover user fee balances, including user fee balances under the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Amendments (GDUFA), and the Medical Device User Fee Amendments (MDUFA).

As it states for those that already paid fee for PDUFA activity is still going on they are not accepting new ones so therefore Irokos drug should be still approved on time! This is from FDA site here is the link!

http://www.fda.gov/ForIndustry/ucm370652.htm
 






Anonymous said:
This document summarizes the anticipated scope of FDA’s activities beginning on October 1, 2013, and continuing until the date of enactment of an FY 2014 appropriation or Continuing Resolution for FDA (the “lapse period”). Please note that FDA’s anticipated activities are subject to resource constraints on the Agency due to the lapse in appropriations and may change in the event of a protracted lapse period.

Overview
During the lapse period, FDA activities related to medical products generally will be limited to the following:
Excepted work involving the safety of human life or the protection of property, including Criminal law enforcement work; and
Activities funded by carryover user fee balances, including user fee balances under the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Amendments (GDUFA), and the Medical Device User Fee Amendments (MDUFA).

As it states for those that already paid fee for PDUFA activity is still going on they are not accepting new ones so therefore Irokos drug should be still approved on time! This is from FDA site here is the link!

http://www.fda.gov/ForIndustry/ucm370652.htm
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Exactly. But the idiots don't want to do 5 minutes of research!
 


















Anonymous said:
yes roommates for training. I hope I don't get butt fucked in the middle of the night like I did at my last company!
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I can't believe they have roommates at training! This is an all time low. Not only are they paying the industry but they expect you to have zero down time or privacy for almost two weeks. Your employment is dependent on your performance at training. It is unfathomable that you would not have a room to yourself to study. They are taking you away from your families during peak holiday season and at the end of the day you can't even retreat to your room to have a private conversation with your kids or spouse.
Additionally in a stressful environment you have ZERO DOWN TIME! Come on Iroko! This doesn't make your team feel valued. It just shows us that the corners you cut will be at the expense of your sales force from Day 1. You are launching a company and 2 new products. Do t you think you would want to start with good morale?
 






Anonymous said:
I can't believe they have roommates at training! This is an all time low. Not only are they paying the industry but they expect you to have zero down time or privacy for almost two weeks. Your employment is dependent on your performance at training. It is unfathomable that you would not have a room to yourself to study. They are taking you away from your families during peak holiday season and at the end of the day you can't even retreat to your room to have a private conversation with your kids or spouse.
Additionally in a stressful environment you have ZERO DOWN TIME! Come on Iroko! This doesn't make your team feel valued. It just shows us that the corners you cut will be at the expense of your sales force from Day 1. You are launching a company and 2 new products. Do t you think you would want to start with good morale?
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Agree 1000%

I accepted the offer iroko and I can tell you we don't want this!!! No roommates
 






Jesus Christ!!! What a bunch of ungreatful whinners!!! If you people do not like sharing a room at training, or anything else associated with this position and the offers you received, get the hell outta here and leave the job open for someone who does appreciate it, and needs it!!!
 






I agree! This position does require you to be college educated! So you went to school and had to pass several courses with several roommates, but you can't study with a roommate for less than two weeks? It's not like you are chained to your room if you need to step out and have some privacy do so! Damn all of this whining I could only imagine your loved ones will celebrate your nearly two week absence. I hope neither one of you are my roommate because I can't tolerate cry babies! This job will be full of barriers out in the field if you can't figure out how to study maybe this isn't for you.
 










































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