Drugs

Guide on PH Waivers for Certain Generics

FDA has released a final guidance entitled “Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use.” The document describes how the agency intends to evaluate a request for a waiver, concerning a pH adjuster, of the regulatory requirement that a drug product intended for parenteral, ophthalmic, or otic use generally “must contain the same inactive ingredients and in the same concentration as the reference listed drug identified by the applicant.” The guidance also provides recommendations regarding the timing and process for requesting such waivers.

FDA notes that the guidance is intended to assist ANDA applicants that reference a reference listed drug (RLD) intended for parenteral, ophthalmic, or otic use but are seeking approval of a drug that is qualitatively or quantitatively different from the RLD with respect to a pH adjuster. It says it is intended to identify the type of information FDA may generally consider in evaluating a waiver request for pH adjusters in generic drug products intended for parenteral, ophthalmic, or otic use.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome