Rare Bladder Disease Assay, Incontinence Treatment Urged
This article was originally published in The Gray Sheet
Discovery of a protein in the urine of interstitial cystitis (IC) sufferers may lead to development of a diagnostic for the disease, according to Vicki Ratner, MD, president of the Interstitial Cystitis Association
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FDA approval of Rochester Medical's FemSoft insert for female stress urinary incontinence on Sept. 30, the final day of the federal government's fiscal year, apparently put the agency's total number of approved, original premarket approval applications for the year at 33, down from 42 in 1998 and 46 in 1997.
A 2008 law that limited exclusivity for certain antibiotics to three years does not apply to Allergan’s Avycaz, which combines an approved old antibiotic active moiety and a new active moiety, CDER exclusivity board concludes.
AstraZeneca and Novavax have not filed EUAs for their vaccines, and they never might. The pathway remains viable in the short-term, but as BLAs are approved and supplies are no longer short, the window may close.