Nov/05/2009 07:39
Some of the
presentations that are going to be given at the
FDA hearings are starting to show up online and
although they maybe great for marketers and
eMarketing people at conferences the FDA/DDMAC
people are quite different in how they like their
data. The first rule of thumb when presenting is
"know your audience" and I can tell you first
hand that they like less fluff (pictures, big
bullets,) and more of a scientific approach to
ANYTHING. Read
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Tags: Social Media
Oct/19/2009 06:34
Amgen today
announced that the FDA has issued a Complete
Response Letter for the Biologic License
Applications Prolia (denosumab) in the treatment
and prevention of postmenopausal osteoporosis.
The FDA issues Complete Response Letters to
request additional information needed to complete
the review of applications for product approval.
In additional news Novartis suffered a setback
for one of its most promising experimental drugs
after the U.S. health regulator said it wanted
more information on the proposed dosage for the
Swiss drug maker's smoker's cough treatment.
Welcome to a more political get tough FDA.
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Tags: FDA
