Received a 483? The Clock is Ticking.
Updated: 2012-07-31 12:12:52
If your company has ever received a 483 from FDA, you likely had a ton of questions about how to respond, how to make things right, and fast. With new agency enforcement policies in action since 2009, companies are expected to respond to 483s within 15 business days. What's the ...

Tomorrow opens the Biopharmaceutical Manufacturing Partnerships conference in Philadelphia, in coordination with CBI and Pharmaceutical Technology magazine. Experts are expected to speak on number of key outsourcing issues including effective due diligence, good procurement practices, QbD implementation, tech transfer strategies, and emerging business models.
I'll be there as will be Patricia ...
Dr. Lisa Fitzpatrick is medical director of the Infectious Diseases Care Center at United Medical Center in Washington,D.C., and now has about 100 HIV-positive patients. From 2005 to 2007, she also was the Centers for Disease Control and Prevention chief of party for the Caribbean. She spoke at several events in and around the conference, [...](Read more...)
Editor’s Note: We had opportunities to catch up with so many great partners on so many important issues while at the XIX International Conference on AIDS (AIDS 2012) last week, we’ll continue bringing you interviews this week and next. In this conversation from AIDS 2012, Dr. Ron Valdiserri, Deputy Assistant Secretary for Health, Infectious Diseases...
Today is the last day of AIDS 2012, the first International AIDS Conference to be held in the United States in more than 20 years. AIDS 2012 helped crystallize the extraordinary opportunities—and serious challenges—that lie ahead as we work to bring about an AIDS-free America. Since the last International AIDS Conference was held in the United...
In his remarks at the Monday plenary of the XIX International AIDS Conference (AIDS 2012), Phill Wilson, Founder and Executive Director of the Black AIDS Institute and member of the Presidential Advisory Council on HIV/AIDS, gave delegates an update on the epidemic in the United States. “We are at a deciding moment in the trajectory...
In Tanzania, an east African country home to 46.2 million people where the national HIV/AIDS prevalence rate is 5.7 percent, the domestic HIV/AIDS response accounts for 10 percent of the national budget, or about $20 million per year. Sixty-five percent of government funding finances antiretroviral therapy (ART). Still, there is a gap of financing of [...](Read more...)
Driven underground by laws and discrimination, their needs for information ignored in much of the global AIDS response, social media provided a refuge but also risks for members of sexual minorities in countries around the world, panelists agreed Thursday. But, representatives of groups from Thailand, the Netherlands, Morocco and Cameroon said, social media and communications [...](Read more...)
“The 1,200 wealthiest people in the world have about $4.2 trillion in wealth,” said Kent Buse, a senior advisor on policy and strategy at UNAIDS. If that super elite group contributed 0.1 percent of their wealth, he said, it would pay for all of global health. Buse opened what was a sobering discussion about the [...](Read more...)
Despite much disruption from protesters – to the visual and audible discontent of event moderator and former Senate Majority Leader Bill Frist (R-TN) – U.S. Congressional leaders were able to get the point across Tuesday that in order to defeat AIDS support must come from both sides of the aisle on Capitol Hill. Rep. Barbara [...](Read more...)