FDA Policy/General

Latest Federal Register Notices

Clinical Trial Enrichment Strategies Guide
Federal Register notice: FDA makes available a final guidance entitled “Enrichment Strategies for Clinical Trials to Support Demonstration of Effectiveness of Human Drugs and Biological Products.” 03/15/2019

Guide on Hematologic Disorders Drug Development
Federal Register notice: FDA makes available a final guidance entitled “Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals.” 03/15/2019

Draft Guide on Clinical Trial Sponsor Monitoring
Federal Register notice: FDA makes available a draft guidance entitled “A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers.” 03/15/2019

Guidance on Animal-sourced Materials in Devices
Federal Register notice: FDA makes available a final guidance on “Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices).” 03/15/2019

Info Collection Extension for Accredited Person Inspections
Federal Register notice: FDA seeks comments on an information collection extension for “Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002.” 03/14/2019

FDA Updates ‘Modifications to the List of Recognized Standards’
Federal Register notice: FDA posts an updated “Modifications to the List of Recognized Standards, Recognition List Number: 051.” 03/14/2019

Draft Guide on Cancer Trials Eligibility for HIV Patients
Federal Register notice: FDA makes available a draft guidance entitled “Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections.” 03/14/2019

Animal Drug Regs Amended to Reflect Application Actions
Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during July, August, and September 2018. 03/14/2019

Draft Guide on Pediatric Cancer Trial Eligibility
Federal Register notice: FDA makes available a draft guidance entitled “Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients.” 03/13/2019

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