Sept. 25, 2012 | Vol. 11 No. 188 | Full Issue in PDF Format
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Generic-drug makers filing ANDAs and drug master files should provide six months of stability testing data, including accelerated and long-term conditions, and data from three pilot scale batches, or two pilot batches and one small scale batch, the FDA’s Office of Generic Drugs (OGD) says in new draft guidance on stability testing.
CINCINNATI — The FDA will issue guidance detailing what information drugmakers should share with contract manufacturing organizations (CMO) hired to work on their products, FDA officials say.
Novartis’ experimental heart failure drug RLX030 reduced deaths in patients with acute heart failure (AHF) in a Phase III study, setting it up for a 2013 regulatory submission.
The Senate early Saturday passed a fiscal 2013 spending extension that would keep the federal government and FDA funded at current levels through March 27.
The FDA is allowing ViroPharma and Halozyme Theraputics to move forward with clinical studies of subcutaneous Cinryze in combination with the human hyaluronidase enzyme rHuPH20 to prevent angioedema attacks.
The FDA is creating a task force to support development of new antibacterial drugs.
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