FDA Plans Osteoporosis Guidance Update
This article was originally published in The Pink Sheet Daily
FDA is seeking comments to update a guidance on development of products for postmenopausal osteoporosis
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“We are prepared to enter discussions toward a decree at FDA’s earliest convenience,” Able says in letter to FDA. Company is pursuing consent decree instead of responding to FDA Form 483 report citing manufacturing deficiencies. The letter follows CEO Maury’s resignation the previous day.