Mar/04/2010 09:48
Welcome to a new
tougher FDA. Not only are they increasing their
regulatory oversight they intend to put people in
jail. The FDA plans to increase prosecutions of
pharmaceutical and food industry executives as
part of an effort to refocus its criminal
division which has been under attack in Congress
and is criticized in a new government report, the
WSJ said this morning. Read More...
Tags: Food
Feb/21/2010 06:50
Attention DTC
marketers: your approval process for TV ads just
became a lot harder. In a letter to the makers of
Aricept DDMAC objected to the creative content as
follows "these presentations imply that, as a
result of Aricept treatment, patients’ cognitive
and daily functioning, specifically aspects of
attention and focus, orientation, communication,
and social interaction and engagement, will be
restored to normal." as an overstatement of
efficacy. Read
More...
Tags: Aricept
Feb/04/2010 10:25
And you thought
Cialis was just for men with ED. Adcirca (Cialis
40mg) just received a letter from the FDA
for omitting
key risk information from their website and
for misleading patient videos. United
Therapeutics licensed the rights to develop,
market, promote and commercialize Adcirca for
pulmonary hypertension in the United States
and Puerto Rico from Eli Lilly & Company
in November 2008. Read
More...
Tags: Adcica
