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Biosimilars slated for 12 years market exclusivity
IN A MOVE applauded by brand name manufacturers, the Senate Health, Education, Labor and Pensions Committee and its House counterpart voted in July...
Medical Marketing and Media, 09/01/09 by Dickinson, James G · More from publication -
'Pay-for-delay' generic deals illegal
THE OBAMA administration's Justice Department says that socalled pay-for-delay arrangements in which an innovator drug company pays a generic drug...
Medical Marketing and Media, 09/01/09 by Dickinson, James G · More from publication -
DDMAC enforcement up significantly
WARNING LETTERS and untitled letters issued by the FDA's Division of Drug Marketing. Advertising and Communications are up 60% over the past 12...
Medical Marketing and Media, 08/01/09 by Dickinson, James G · More from publication -
FTC chief calls for a ban on generic pay-for-delay deals
IN THE WAKE of an FTC report that so-called "authorized generics" lower prices, commission chairman Jon Leibowitz says Congress should pass pending...
Medical Marketing and Media, 08/01/09 by Dickinson, James G · More from publication -
FDA hears transparency boost ideas
AT ITS FIRST public hearing in June, the FDA's new Transparency Task Force heard diverse ideas ranging from greater news media access to FDA staff...
Medical Marketing and Media, 08/01/09 by Dickinson, James G · More from publication -
As I See It
Whether or not Congress elects to reorganize the FDA, the Obama administration's new leadership team at the agency vows changes are on the way,...
Medical Marketing and Media, 07/01/09 by Dickinson, James G · More from publication -
Hamburg: Judge the agency on public health
FDA COMMISSIONER Margaret Hamburg and principal deputy commissioner Joshua Sharfstein said in a June 11 New England Journal of Medicine...
Medical Marketing and Media, 07/01/09 by Dickinson, James G · More from publication -
FDA's Goodman urges transparency
PDA CHIEF scientist Jesse Goodman, recently named acting deputy commissioner for scientific and medical programs, said in May that he has been...
Medical Marketing and Media, 07/01/09 by Dickinson, James G · More from publication -
Comparative effectiveness will boost R&D: Woodcock
THE FDA'S director of drugs, Janet Woodcock, believes the movement toward comparative effectiveness research will lead to a more internationally...
Medical Marketing and Media, 06/01/09 by Dickinson, James G · More from publication -
FDA to speed up drug enforcement
THE FDA'S drug center is increasing and speeding up its enforcement actions, according to compliance director Deborah Autor. Addressing the Food...
Medical Marketing and Media, 06/01/09 by Dickinson, James G · More from publication
