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reviewer directly Yes, if there had been a question he could not answer himself, such as a question about the drug s status He would not tell the reviewer why he wanted to know But such a query from him, as commissioner, would not be a big deal, Friedman claimed I called and asked questions all the time Another midlevel official, who would not let his name be used because the topic is so sensitive, stammered a bit as he described the conditions under which he would pass a congressional call on to a reviewer I would only do that, most likely, if the person [from Congress] I m talking to tells me they [the reviewer] seem to be doing something that s not consistent with our policies, then I would talk to the reviewer.

that you were trying to get out of writing to me The thought was totally unexpected that you would ever change or that something would come into our lives that could affect us so adversely When you were finally diagnosed, I was shocked, confused, and upset I didn t want the doctors to find anything I wanted everything to be fine and to stay as it was After the initial shock, I was both confused and concerned I had so many questions but was almost afraid to ask them for fear of what the answers would be I was concerned for you and what this meant for you Where were you now in this progressive disease, and where would you go Then I felt another wave of shock and the misapprehension that Parkinson s disease could affect my baby and my future children I was really frightened.

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Could this disease take over my children s bodies and my own as well In the days and weeks that followed, I wanted to learn as much as I could about it, and I wanted you to do the same I think I was hoping to find a way to get it out of our lives I had moved from confusion to anger that this was happening to us Then I got tired of hearing about Parkinson s and just wanted to forget about it I realize I was very selfish and often I still am Maybe I felt the Parkinson s threatening the closeness we had always shared, slowly building a wall between us Or am I myself building the wall I am not sure I resent the Parkinson s, and the resentment spills over I wanted our relationship to remain the way it was.

I miss all the things we used to do and all the laughter I fear a possible role reversal, for which I may not ever be strong enough My feelings are often in turmoil about you: love, fear, resentment, anger, and guilt I know that I don t always meet your needs My own family and work take so much of my time now But I want you to know that I am proud of you, proud that you have continued your teaching role in forming the support group, that you are writing this book, that you continue to reach out to people, and that you continue to enjoy meeting new faces and seeing new places..

The FDA Glossary de nition of Operational Quali cation (OQ) is as follows:

20 8

Or, he added, he and the reviewer may chat in an informal sense, Oh, So-and-So called Could that make the reviewer feel under pressure The manager quickly backed off: I m doing that less and less as time goes on It s not even worth talking about If it happened to be something that s a fairly controversial topic and a highly publicized topic They should just know that there s extreme interest in the topic Once the reviewer learns of the politician s phone call, he or she will usually have one of three reactions, Koepke said One is, they become very cowed One is, they let it roll off their back One is, every application that comes in from that company is looked at very closely that is, the reviewer overcompensates by becoming more demanding.