Details of the results of the four studies will be published in The Lancet on August 29.
Information on how to prepare and send postmarket safety reports for devices and for drugs and biologics is contained in draft guidance documents.
If approved, roflumilast, a once-a-day oral tablet, will be the first in an entirely new class of treatment for COPD.
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Obtaining a drug or biologic under an expanded access program may be an option for some patients who are not able to enroll in clinical trials.
May contain forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding clinical trials, out-licensing arrangements (including the timing and amount of contingent paymen
People who are extremely obese -- 80 pounds or more heavier than a normal weight -- die three to 12 years sooner than normal-weight individuals. But people who are just overweight or moderately obese tend to live a normal life span, a new study found, acc
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Advanced online activities such as blogs, podcasting, professional online communities, and wikis
The proposed regulation for medical devices would require manufacturers, importers and user facilities to submit reports to the FDA in electronic format, which will be loaded into the MAUDE database.
One 12 month study was conducted in 246 centres in 10 countries and the second was conducted in 221 centres in eight countries.
Diarrhea, nausea and headache were the commonest reasons for discontinuation.
* The duration is how long the insulin lasts in your body ? the amount of time it keeps lowering your blood sugar.
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* The duration is how long the insulin lasts in your body ? the amount of time it keeps lowering your blood sugar.