Drugs

Comments on FDA Guidance Best Practices

The Parenteral Drug Association (PDA) says an FDA “Draft Report and Plan on Best Practices for Guidance” does not provide an overview and metrics on the initiatives in an agency 2011 good guidance practices report. PDA says it suggests that FDA include a section in the draft report with the missing information or publish the data on the agency Web site.

The AdvaMed comment letter raises these issues:

expanded use of guidances without advance opportunity for comment could undermine good policymaking;
FDA should take steps to facilitate the public’s understanding of the evolution of specific guidances;
FDA should enhance transparency surrounding guidance development;
support for non-binding use of templates, when appropriate, and other non-traditional ways to disseminate information; and
FDA should address and clarify instances in which guidance contains binding aspects.

In its letter, the Association for Accessible Medicines (AAM) says it strongly supports FDA efforts to issue timely and informative guidance that assists the regulated industry in complying with regulatory requirements. While the draft report says the number of guidances issued by the agency has increased significantly in the past 20 years, the AAM urges a focus on guidance quality rather than quantity and says FDA should ensure that published guidance continue to reflect its current thinking. “The focus on publishing new material often means draft guidances remain in draft status for extended periods,” it says. “This creates uncertainty about whether the draft guidance continues to reflect the agency’s current policy, even apart from the fact that draft guidance is not supposed to be implemented before it is final.”

Finally, Pharmaceutical Research and Manufacturers of America says it commends FDA for its “longstanding commitment to and leadership in providing guidance to interested stakeholders, and to promoting transparency, predictability, and efficiency through good guidance practices.” It identifies several areas where it believes the agency could improve its practices related to developing and issuing guidances.

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