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Friday, July 22, 2011

Not liking regulatory job

I've been asked to facilitate notification of our products since our regulatory officer resigned. Nobody seems to want her job. Now I know why.

I went to FDA, Alabang yesterday to notify 4 products and have some layouts reviewed. I've waited for 2 hours only to find out that the FDA logo on the notification forms is incorrect. The culprit would be my old computer in the office where I downloaded the form on the website. I couldn't seem to view logos on that computer, ggrrrhh. Anyhow, my trip there wasn't wasted because I was able to have 2 layouts reviewed. There was only one correction on one layout but the other one have major issues because the claims doesn't seem to fall in to cosmetics but as a drug already.

I had no choice but to go home and correct the mistake on the notification form the following morning.

After I downloaded and filled up the correct notification form, I was having second thoughts on the balm and ointment part that we declared. It was intended for drugs and not for cosmetics. My boss insisted on those terms so I went to FDA and filed it.

My hunch is correct, those products were rejected again! The regulatory officer at FDA told me what to write but my boss said that before I change anything, marketing needs to be informed first.

Well, there goes my second day at FDA. One product was approved but I couldn't notify it because the cheque
I have is intended for all those products that I was supposed to notify.

Now, I'm hungry and tired. Hope BF relieves my stress, because I'm going to meet him later.

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