Drugs

ANDA Submission Content and Format Guide

FDA has released a final guidance entitled “ANDA Submissions — Content and Format” that details the information that should be provided in each section of the common technical document format. The document also identifies supporting guidance documents and recommendations issued by FDA to assist applicants in preparing their ANDA submission. Additionally, it addresses the information that an applicant should include to ensure that a complete, high-quality application is submitted.

The guidance was issued as part of the agency’s Drug Competition Action Plan. “A key objective is to reduce barriers to generic drug access,” FDA commissioner Scott Gottlieb is quoted in a release as saying. “As part of that goal, we want to reduce the number of cycles of review that generic applications undergo in order to make the generic approval process more efficient and shrink the time it takes for a safe and effective generic drug to reach the market. We’ve been implementing measures to improve the efficiency of our reviews and to prioritize applications for generic versions of medicines that may lack competition. But we’re also continuing to look at how we can assist companies in submitting higher-quality and more complete applications that are less likely to undergo multiple cycles of review before receiving FDA approval. For example, historically, it’s taken about four cycles of review for an Abbreviated New Drug Application to reach approval.

“These additional review cycles,” Gottlieb continues, “weren’t always needed because the product didn’t meet the agency’s standards for approval. Often it was because the application was submitted without all the information necessary to prove that the generic drug meets the requirements for approval and not because the product itself was deficient. These multiple cycles of review are costly and inefficient. The guidance that we’re issuing today seek to reduce application cycling by clarifying for industry how they can submit complete, high quality applications from the start.”

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