Advancing Therapeutic Innovation and Regulatory Science - DIA2013 Preliminary Program available

Preliminary Program Now Available Online With our continued efforts to , DIA decided for the first-time to go digital with the Preliminary Program! Everything you need to know about DIA 2013 49th Annual Meeting can be found in the digital version: • Schedule At-A-Glance • Monday-Thursday Highlights • Global Regulatory Presence • Networking Opportunities • Quick Guide to this Year's Program • Getting to Boston, Hotel, and Travel • 450+ Exhibiting Companies • 250+ Sessions TransCelerate's Collaborative Approach to Risk-based Monitoring: The Methodology Wednesday, June 26 | 1:45-3:15PM Keynote Speaker: Daniel Kraft, MD, Executive Director, FutureMed Monday, June 24 | 8:30AM Start Planning Your DIA 2013 49th Annual Meeting Experience Today! View Preliminary Program Overview | Preliminary Program | Register Today

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Generic drugmakers concerned over FDA turmoil

Director of OGD resigns after 8 months as his office loses staff

Read more: Generic drugmakers concerned over FDA turmoil - FiercePharma http://www.fiercepharma.com/story/gerneric-drugmakers-concerned-over-fda-turmoil/2013-03-15#ixzz2NtWD0aBy
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Generic drugmakers are feeling a little taken advantage of. They produce 80% of the drugs used in the U.S. Their products are saving federal health programs billions of dollars, and they are now helping cover some of the FDA budget through user fees. But it took the FDA two years to fill the top position at the Office of Generic Drugs (OGD), and then after 8 months the new director, Dr. Gregory Geba, is calling it quits. His resignation today comes as about half the OGD staff is being reassigned to a new office overseeing quality.

Ralph Neas--Courtesy of GPhA

"Now, with Dr. Geba's departure, we are significantly concerned about further disruption at the FDA," Ralph Neas, CEO of the Generic Pharmaceutical Association (GPhA), said in a statement Thursday. "These vacancies and changes hold the potential to distract from the critical mission of the OGD, and slow the flow of information, guidance, and approvals needed to achieve an optimal generic drugs market for patients, payers and the health care system ... We trust that FDA is doing everything possible to ensure that the Office of Generic Drugs is fully staffed so that it can continue its regulatory mandate and GDUFA implementation."


Read more: Generic drugmakers concerned over FDA turmoil - FiercePharma http://www.fiercepharma.com/story/gerneric-drugmakers-concerned-over-fda-turmoil/2013-03-15#ixzz2NtW8WKaa
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Rare-disease drugs won't help out-of-work pharma reps

Pharma-watchers know that rare diseases are all the rage these days. With primary-care blockbusters falling to generic competition, drugmakers are zeroing in on ultra-expensive treatments for conditions that affect only a few hundred patients, rather than millions of them. And companies don't just benefit from the ability to command high prices. They also save on sales reps and ad campaigns.
For pharma sales reps, it may seem like adding insult to injury, after the past several years of mass layoffs. But as Medical Marketing & Media reports, companies won't be staffing up much to launch rare-disease drugs. Take Corcept Therapeutics ($CORT), now preparing to roll out its Cushing's syndrome drug Korlym. "I don't have to hire an army of sales reps," Corcept VP Steven Lo tells MM&M.


Read more: Rare-disease drugs won't help out-of-work pharma reps - FiercePharma http://www.fiercepharma.com/story/rare-disease-drugs-wont-help-out-work-pharma-reps/2012-04-02#ixzz1quCpDDXE
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