Drugs

FDA, Other Regulators Begin New Antimicrobial Agent Talks

A tripartite meeting last week between FDA, European Medicines Agency and Japan’s Pharmaceuticals and Medical Devices Agency shared information on data requirements for approving new antimicrobial agents under limited circumstances (limited number of patients, limited therapeutic tool, targeting single species). The regulatory agencies agreed that a robust response to the problem of antimicrobial resistance must be multi-faceted and that the regulatory approach for evaluating antibacterial agents is only one element of the total response that is required to encourage and accelerate new antibacterial drug development to meet patient needs. The regulators’ discussion led to the following agreements:

* It is appropriate to exercise flexibility with regard to the requirements for clinical development programs for antibacterial agents, especially for new agents that may be used to treat patients with limited treatment options because of antimicrobial resistance;

* There is benefit in further convergence on the data requirements for the approval of antibacterial agents;

* It may be appropriate to accept a greater degree of uncertainty regarding the benefit-risk balance when developing new antibacterial agents that can be used to treat patients with limited treatment options, e.g. it may be acceptable to conduct trials in smaller numbers of patients than would usually be required;

* It is important to conduct sound analyses of the pharmacokinetic-pharmacodynamic relationship for the purposes of selecting dose regimens for study in clinical trials, including regimens that may minimize the risk of selecting for resistant organisms;

* There is value in developing clinical trial networks to facilitate the evaluation of new antibacterial agents and the development of such networks is encouraged;

Additionally, they agreed that there is value in continuing such discussions and the next meeting is proposed for next spring. At that time, discussions will also address not only the pre-approval clinical development programs but also activities conducted in the post-approval period.

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