Drugs

Changes Sought in LPAD Draft Guidance

Pharmaceutical Research and Manufacturers of America says it generally supports the FDA proposed limited population pathway for antibacterial and antifungal drugs (LPAD) and provides comments on the draft guidance: need for revisions to accurately reflect statutory language; FDA LPAD pathway eligibility determinations made at a time of approval may discourage pathway use based on sponsor uncertainty; FDA should not inadvertently discourage development under the pathway of medicines to treat rare diseases.

The Biotechnology Innovation Organization says the draft guidance provides welcome clarity for sponsors developing antibiotic and antifungal drugs under the pathway created by the 21^st Century Cures bill. It offers these comments: additional examples of products for which the LPAD approval pathway might be valuable or necessary would be helpful; additional clarification is needed to inform clinical trial design for LPAD products; FDA should consider how new initiatives to modernize drug development and review may be applied to LPAD products; additional guidance is requested on labeling; and clarity is needed on communication of promotional material.

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

Read more

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