Taka Update September 19, 2012
Fish delivery and more
Tuna situation is same as last week. I asked our supplier for this issue. The reason we cannot get good tuna is very simple. It is hurricane. Many tropical storms are available around central Atlantic Ocean. Fishermen don’t want to die for it. That’s why. I can tell it. We could get good tuna before Issac came to Gulf of Mexico. After Issac, everything had changed. We could net get good tuna.
Other fish are fine. Uni is available and quality is getting better.
Weight Control and Golf
I lost my weight very at moment. That was Monday morning after 2 days of Japan Fest event. It was 168.4 lbs. I really worked hard last week. 4 hours sleep on Friday night, 5 hours sleep on Saturday night. And I lost 3 lbs. But it came back to 170.2 lbs this morning. I feel fine with this weight.
No play golf last weekend, and I will not play this Sunday. I met Dustin Johnson yesterday. He looked good.
After No more Highchair
People still bring their babies or kinds. They bring their tools and make comfortable their kids. The only a couple came and left because of no highchairs.
So, it’s same and does not matter. They don’t like babysitting and bring their families.
Babies cry and scream before 7pm. That’s why we do happy our and reduce drink prices.
Safety Monitoring of Drugs Receiving Pediatric Marketing Exclusivity
The Food and Drug Administration (FDA) Modernization Act provided for an additional 6-month period of marketing exclusivity to companies that perform pediatric drug trials in response to an FDA-issued written request. Because many safety concerns cannot be detected until after the introduction of a product to a larger and more diverse market, the Best Pharmaceuticals for Children Act required the FDA to report to the Pediatric Advisory Committee (PAC) on adverse events occurring during the 1-year period after granting pediatric exclusivity. We sought to describe the PAC’s recommendations made in response to safety reviews informed by data from the FDA’s Adverse Event Reporting System in 67 drugs granted exclusivity.
PAC meetings and data presented by the FDA for all drugs were reviewed from June 2003 through April 2007. We divided the drugs into 2 groups: those that were returned to routine adverse event monitoring and those that had specific PAC recommendations.
Forty-four (65.7%) drugs were returned to routine monitoring for adverse events. The PAC, sometimes working with other advisory committees, recommended label changes for 12 (17.9%) drugs, continued monitoring for 10 (14.9%), production of MedGuides for 9 (13.4%), and an update on label changes resulting from discussions with the sponsor for 1 (1.5%) drug. Some drugs had more than 1 action. Several of the adverse events revealed during this process were rare and life-threatening.
Safety monitoring during the early post-marketing period is crucial to detect rare, serious, or pediatric-specific adverse events. Fortunately, the majority of drugs given exclusivity had no adverse events of a frequency or severity that prevented a return to routine adverse event monitoring.
Taka sushiandpassion www.sushiandpassion.blogspot.com
375 Pharr Rd. Atlanta GA 30305 Reservation 404-869-2802