Drugs

Latest Federal Register Notices

FDA Files Annual Reports on Closed Panel Meetings
Federal Register notice: FDA has filed with the Library of Congress annual reports of certain FDA advisory committees that held closed meetings during fiscal year 2016.The annual reports are required by the Federal Advisory Committee Act. To view the notice, click here.
7/3/2017

Approved Information Collection Listing
Federal Register notice: FDA has published a list of information collections that have been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view the notice, click here.
7/3/2017

Comments Sought on Safety Communication Surveys
Federal Register notice: FDA is seeking comments on an information collection on “FDA Safety Communication Readership Surveys.” Such surveys help FDA to evaluate the clarity, timeliness, and impact of safety communications by querying a sample of recipients. Understanding how the target audiences view these publications will aid in determining what, if any, changes should be considered in their content, format, and method of dissemination. To view the notice, click here.
7/5/2017

Medical Imaging Drugs Panel Renewed for 2 Years
Federal Register notice: FDA has announced the renewal of the Medical Imaging Drugs Advisory Committee. The agency has determined that it is in the public interest to renew the advisory committee for an additional two years. The new charter will be in effect until 5/18/2019. To view the notice, click here.
7/5/2017

Draft Guide on Drug Product Identifier Requirements
Federal Register notice: FDA has announced the availability of a draft guidance on “Product Identifier Requirements Under the Drug Supply Chain Security Act— Compliance Policy.” The document describes FDA’s intention to provide firms with additional time to comply with requirements related to product identifiers under the Act. The guidance also addresses certain requirements for repackagers, wholesale distributors, and dispensers to only engage in transactions involving products with product identifiers and to verify the product identifier when investigating suspect product, in addition to repackager and wholesale distributor requirements related to saleable returned products. To view the notice, click here.
7/6/2017

Joint Panel to Review NDA for Pain Drug
Federal Register notice: FDA has announced a 7/26 joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The panel will review and discuss an Intellipharmaceutics Corp. NDA for oxycodone hydrochloride extended- release oral tablets with a proposed indication of management of moderate-to-severe pain when a continuous around-the-clock analgesic is needed for an extended period of time. The product has been formulated with properties intended to deter abuse. To view the notice, click here.
7/6/2017

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