Drugs

Drug Limited Population Pathway Guidance

FDA has published a guidance, Limited Population Pathway for Antibacterial and Antifungal Drugs, with information on how the agency is implementing a section of the 21^st Century Cures Act that established the limited population pathway for antibacterial and antifungal drugs (LPAD pathway). The document is intended to assist sponsors in developing certain new antibacterial and antifungal drugs under the LAPD pathway and also is to assist applicants in developing labeling, including prescribing information, patient labeling, and carton container labeling, that incorporate certain statements required by the law.

The guidance does not address specific recommendations on the design of clinical trials for drugs developed under the LAPD pathway.

Contents of the guidance are Introduction, Background, LAPD Pathway Defined, Relationship to Other Programs, Considerations for Approval of Drugs Under the LAPD Pathway, Process for the LAPS Pathway, and Conditions of Approval Under the LAPD Pathway.

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