FDA orders safety studies for some asthma drugs | Reuters

U.S. health regulators have ordered drugmakers to conduct clinical trials involving a total of 53,000 patients to test the safety of a controversial class of inhaled asthma drugs that are already on the market.

The trials are being required to demonstrate the safety of medicines known as long-acting beta-agonists (LABAs) when used in combination with inhaled steroids, another class of asthma drugs, the U.S. Food and Drug Administration said on Friday.

LABAs to be studied are AstraZeneca's Symbicort, GlaxoSmithKline's Advair Diskus, Merck & Co's Dulera, and Novartis AG's Foradil.

via reuters.com

--

******************************************************
For Health Information you can use, Follow, Connect, Like us on (Most Invites Accepted):
http://www.nursefriendly.com/social/

Twitter!
http://www.nursefriendly.com/twitter

Facebook:
http://www.nursefriendly.com/facebook

What's New:
http://www.nursefriendly.com/new/

Blogger:
http://4nursing.blogspot.com/

Linked In:
http://www.linkedin.com/in/nursefriendly

Nursing Entrepreneurs, Nurses In Business
http://nursingentrepreneurs.ning.com/

StumbleUpon,
http://www.nursefriendly.com/stumbleupon
******************************************************

Sincerely,

Andrew Lopez, RN
Nursefriendly, Inc. A New Jersey Corporation.
38 Tattersall Drive, Mantua New Jersey 08051
http://www.nursefriendly.com info@nursefriendly.com ICQ #6116137
856-415-9617, (fax) 415-9618

150,000 + Nurse-Reviewed & Approved Nursing Links

http://www.4nursing.com
http://www.legalnursingconsultant.com
http://www.nursinghumor.com
http://www.nursefriendly.com
http://www.nursingcasestudy.com
http://www.nursingentrepreneurs.com
http://www.nursingexperts.com

Drug maker cited for not reporting side effects - Health - Health care - msnbc.com

U.S. health regulators have warned Sanofi-Aventis SA's U.S. unit for failing to submit reports of possible serious side effects in a timely manner.

In a January 28 letter made public on Tuesday, the Food and Drug Administration said an early response from the drugmaker and its "promised corrective actions are inadequate to address the deficiencies."

"We remain concerned that your .... adverse drug experience reporting system has not been fully validated, and may have resulted in inaccurate assessment and untimely submission of 15-day alerts," FDA said.

via msnbc.msn.com

Click on the "via" link to read the rest of the article.

******************************************************
Follow, Connect, Like us on (Most Invites Accepted):

What's New:
http://www.nursefriendly.com/new/

Blogger:
http://4nursing.blogspot.com/

Facebook:
http://www.nursefriendly.com/facebook

Linked In:
http://www.linkedin.com/in/nursefriendly

Nursing Entrepreneurs, Nurses In Business
http://nursingentrepreneurs.ning.com/

Twitter!
http://www.nursefriendly.com/twitter

StumbleUpon,
http://www.nursefriendly.com/stumbleupon
******************************************************

Sincerely,

Andrew Lopez, RN
Nursefriendly, Inc. A New Jersey Corporation.
38 Tattersall Drive, Mantua New Jersey 08051
http://www.nursefriendly.com info@nursefriendly.com ICQ #6116137
856-415-9617, (fax) 415-9618

150,000 + Nurse-Reviewed & Approved Nursing Links

http://www.4nursing.com
http://www.legalnursingconsultant.com
http://www.nursinghumor.com
http://www.nursefriendly.com
http://www.nursingcasestudy.com
http://www.nursingentrepreneurs.com
http://www.nursingexperts.com