Drugs

GDUFA 2 Changes Benefit Small Businesses: SBIA

The CDER Small Business and Industry Assistance (SBIA) program says that changes included in the GDUFA 2 agreement now awaiting congressional action address small business concerns that arose under GDUFA 1. In an online SBIA Chronicles, CDER Division of User Fee Management and Budget Formulation generics branch chief Gisa Perez says that one of the primary concerns with GDUFA 1 was that it did not provide any relief for small business. She reports that GDUFA 2 addresses this concern in three ways:

rather than facilities incurring an annual facility fee if they are simply referenced in a pending or approved ANDA as in GDUFA 1, under GDUFA 2 they will be assessed an annual fee only when they are identified in an approved submission;
under the GDUFA 2 user fee structure, there will be three tiers for the annual program fee based on the number of approved ANDAs owned by a firm and its affiliates—large (20 or more approved ANDAs, paying 100% of the fee), medium (6-19 approved ANDAs, paying 40% of the fee), and small (5 or fewer approved ANDAs, paying 10% of the fee); and
within the Finished Dosage Form facility category, GDUFA 2 carves out a subcategory for contract manufacturing organizations defined as independent facilities contracted by ANDA sponsors to manufacture their generic drugs, which will pay only one-third of the annual fee paid by firms that manufacture ANDA products at facilities which they or their affiliates own.

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