FDA Policy/General

Latest Federal Register Notices

DEVICES

Comments Sought on Radiation Product Requirements
Federal Register Notice: FDA is seeking comments on an OMB submission to extend an information collection on reporting and recordkeeping requirements for manufacturers and distributors of electronic products. The requirements are outlined under the agency’s electronic product radiation control program, including the development, issuance, and administration of performance standards to control the emission of electronic product radiation from electronic products. To view the notice, click here.

Draft Guide on Surgical Aspirator Device Labeling
Federal Register Notice: FDA has made available a draft guidance on “Product Labeling for Certain Ultrasonic Surgical Aspirator Devices.” The document provides a specific labeling recommendation to promote the safe and effective use of ultrasonic surgical aspirator devices. The labeling recommendation is being made due to a risk of tissue dissemination and relates to use of these devices in the removal of uterine fibroid. To view the guidance, click here. To view the notice, click here.

DRUGS

Rule Discourages Petitions Seeking to Delay ANDAs
Federal Register Final Rule. FDA has amended certain regulations relating to citizen petitions, petitions for stay of actions and the submission of documents to the agency. In particular, the final rule establishes new regulations to implement certain provisions of the Federal Food, Drug, and Cosmetic Act that implement a congressional desire that petitions not be used to improperly delay approval of ANDAs. To view the rule, click here.

Guidance on Non-inferiority Trials
Federal Register Notice: FDA has made available a guidance on “Non-Inferiority Clinical Trials to Establish Effectiveness.” The document discusses the appropriate use of such study designs to provide evidence on the effectiveness of a drug or biologic. It says that a non-inferiority design is usually used because a superiority study design (drug versus placebo, dose response, or superiority to an active drug) cannot be used. It also gives advice on when non-inferiority (NI) studies intended to demonstrate effectiveness of an investigational drug can provide interpretable results, how to choose the NI margin, and how to test the NI hypothesis. To view the guidance, click here. To view the notice, click here.

Comments Sought on Standardized Study Data Template
Federal Register Notice: FDA has established a public docket to collect comments related to a proposed Study Data Standardization Plan template. The template was developed by a working group under an ongoing collaboration with the Pharmaceutical Users Software Exchange, an independent, non-profit consortium addressing computational science issues. The template will be reviewed to determine whether FDA will recommend its use either as is, or in a modified form, for regulatory submissions of study data. To view the template, click here. To view the notice, click here.

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