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...do not create or confer any rights for or on any person and do not bind FDA or the public. An alternative approach may be used if it satisfies the requirements of the applicable statutes and regulations.
Acute bacterial sinusitis drugs
In the October 30, 2007, Federal Register, FDA announced the availability of a draft guidance document for industry titled Acute Bacterial Sinusitis: Developing Drugs for Treatment. The purpose of this guidance document was to assist clinical trial sponsors and investigators in the development of antimicrobial drug products for the treatment of acute bacterial sinusitis (ABS). FDA's thinking in this area has evolved in...
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