Drugs

Latest Federal Register Notices

Draft Guide on Whether to Submit ANDA or 505(b)(2) Application
Federal Register notice: FDA makes available a draft guidance on “Determining Whether to Submit an ANDA or a 505(b)(2) Application.” 10/13/2017

Panel to Meet on Barricaid Anular Closure Device
Federal Register notice: FDA announces a 12/12 Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee meeting that will discuss and vote on an Intrinsic Therapeutics PMA for the Barricaid Anular Closure Device. 10/13/2017

Draft Guide on Assessing Drug User Fees
Federal Register notice: FDA makes available a draft guidance on “Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017.” 10/13/2017

Cranial Motion Measurement Devices Require 510(k): Correction
Federal Register notice: FDA corrects a final order entitled “Medical Devices; Neurological Devices; Classification of Cranial Motion Measurement Device” that appeared in the 7/28 Federal Register. 10/12/2017

PDUFA e-Submission and Data Standards Public Meeting
Federal Register notice: FDA announces a 3/21/2018 public meeting on “Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.” 10/12/2017

Animal Generic Drug User Fee Reauthorization Meeting
Federal Register notice: FDA announces a 11/2 public meeting entitled “Animal Generic Drug User Fee Act.” 10/09/2017

Animal Drug User Fee Reauthorization Public Meeting
Federal Register notice: FDA announces a 11/2 public meeting entitled “Animal Drug User Fee Act.” 10/09/2017

Regulatory Review Period Determined for Impella 2.5 System
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Abiomed Europe’s Impella 2.5 System. 10/06/2017

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