FDA Policy/General

Latest Federal Register Notices

DEVICES

Class 2 for Computerized Concussion Assessment Aids
Federal Register Final Order: FDA has classified Computerized Cognitive Assessment Aids for Concussion into Class II (special controls). The special controls that will apply to the device are identified in the order and will be part of the codified language for the device’s classification. To view the order, click here.

DRUGS

FDA Guide on Identifying Suspect Drug Supply
Federal Register Notice: FDA has made available a guidance on “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.” The document is intended to aid certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product and specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain. It also describes how trading partners should notify FDA of illegitimate product and sets forth a process for terminating notifications of illegitimate product in consultation with FDA. Additionally, the guidance includes a new section, for comment purposes only, that describes when manufacturers should notify FDA of a high risk that a product is illegitimate. To view the guidance, click here. To view the notice, click here.

Docket Opened for Drug Review Assessment Under PDUFA
Federal Register Notice: FDA has established a docket to obtain comments on the final assessment of the “Program for Enhanced Review Transparency and Communication for New Molecular Entity (NME) New Drug Applications (NDAs) and Original Biologics License Applications (BLAs).” Also, a 3/27/2017 public meeting has been annouced where the final assessment will be discussed and public stakeholders may present their views on the program to date. The program is part of the FDA performance commitments under the fifth authorization of the Prescription Drug User Fee Act. To view the notice, click here.

FDA Determines Regulatory Review Period for Merck’s Gardasil 9
Federal Register Notice: FDA has determined the regulatory review period for Merck’s Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) for patent extension purposes is 2,662 days. Of this time, 2,296 days occurred during the testing phase, while 366 days occurred during the approval phase. To view the notice, click here.

GENERAL

CFSAN Posting Adverse Event Data Files
Federal Register Notice: FDA has made available data extracted from adverse event reports from 2004 to the present for food (including food additives, color additives, and dietary supplements) and cosmetics regulated by CFSAN. The data files are being made publicly available on the agency’s Web site to improve transparency about adverse event reports involving CFSAN-regulated products and increase awareness about reporting the adverse event. To view the data files, 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

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