Drugs

FDA Updates Guidance on Choosing Between ANDA and 505(b)(2) Pathways

FDA has issued a draft revised guidance intended to help drug developers determine whether a proposed product should be submitted through the ANDA pathway under Section 505(j) of the Federal Food, Drug, and Cosmetic Act or through the 505(b)(2) NDA pathway. The document, Determining Whether to Submit an ANDA or a 505(b)(2) Application, revises FDA’s 5/2019 guidance and adds information on duplicates and eligibility for ANDA approval and makes other changes intended to clarify its recommendations.

FDA says it generally will refuse to file a 505(b)(2) application for a drug that is a duplicate of a listed drug and is eligible for ANDA approval. The document also discusses circumstances involving discontinued reference products, petitioned ANDAs, bundled applications and differences in formulation, bioavailability, conditions of use and labeling.

The draft also emphasizes that developers should consult FDA before submitting an application when it is unclear which pathway is appropriate. Prospective ANDA applicants can submit controlled correspondence to FDA's Office of Generic Drugs or request a pre-ANDA meeting. Developers considering a 505(b)(2) application are advised to contact the appropriate Office of New Drugs review division.

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