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FDA Approvals - Nabi Biopharmaceuticals Announces Initiation Of Civacir(R) Phase II 'Proof-of- Concept'


Nabi Biopharmaceuticals Announces Initiation Of Civacir(R) Phase II 'Proof-of- Concept' Clinical Trial (Medical News Today)
Nabi Biopharmaceuticals (Nasdaq: NABI) announced today that it has initiated its Phase II "proof-of-concept" clinical trial for Civacir(R) [Hepatitis C Immune Globulin (Human)]. [click link for full article]

Using Design Controls to Reduce Time to Market (Medical Device Link)
FDA s quality system regulation (QSR) is often perceived by medical product developers as unnecessary overhead. Software developers, in particular, often see it as a nuisance that delays the completion of the development of the product. Actually, just the opposite may be true.

CEL-SCI Receives Green Light From FDA To Proceed With Phase III Cancer Study (Medical News Today)
CEL-SCI Corporation (Amex: CVM), (Germany: LSR) today announced that the U.S. Food and Drug Administration (FDA) has stated in a letter to the Company that, "...the proposed Phase III study may proceed at any time." CEL-SCI's Phase III clinical study is designed to prove that its cancer drug Multikine(R) increases the survival of head and neck cancer patients. [click link for full article]
 

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