FDA Policy/General

Latest Federal Register Notices

Draft Guide on Expedited Notifications on Product Recalls
Federal Register notice: FDA makes available a draft guidance entitled “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C.” 01/19/2018

Draft Guide on Medical Countermeasure Voucher Program
Federal Register notice: FDA makes available a draft guidance entitled “Material Threat Medical Countermeasure Priority Review Vouchers.” 01/19/2018

Debarment Ordered in Unapproved Drugs Case
Federal Register notice: FDA permanently debars William Ralph Kincaid from providing services in any capacity to a person that has an approved or pending drug product application. 01/18/2018

Regulatory Review Period for Forest Labs’ Avycaz
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Forest Laboratories’ Avycaz (ceftazidime pentahydrate and avibactam sodium) was 2,579 days. 01/18/2018

FDA Withdraws 22 ANDAs No Longer Marketed
Federal Register notice: FDA withdraws approval of 22 ANDAs from multiple applicants. 1/17/2018

Proposed Rule on CDRH Supervisory Review of Certain Actions
Federal Register proposed rule: FDA proposes to implement regulations regarding internal agency supervisory review of certain decisions related to devices regulated by CDRH. 01/17/2018

OMB Approval Sought for Genomic Test Info Collection
Federal Register notice: FDA submits for OMB clearance a new information collection entitled “Use of Public Human Genetic Variant Databases To Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics — OMB Control Number 0910.” 01/17/2018

Guide on UDI Enforcement Discretion for Certain Devices
Federal Register notice: FDA makes available a guidance entitled “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices.” 01/16/2018

Workshop on Device Conformity Assessment to Recognized Standards
Federal Register notice: FDA announces a 5/22-23 public workshop on “Accreditation Scheme for Conformity Assessment of Medical Devices to FDA-Recognized Standards.” 01/16/2018

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