FDA Policy/General

Latest Federal Register Notices

Rare Disease Drug Development Guide
Federal Register notice: FDA issues a draft guidance, Rare Diseases: Common Issues in Drug Development, to assist drug and biological sponsors in conducting more efficient and successful drug development programs. 02/01/2019

Guide on REMS Assessment: Planning and Reporting
Federal Register notice: FDA makes available a draft guidance entitled REMS Assessment: Planning and Reporting. 02/01/2019

Coordinating Antimicrobial Drug/Susceptibility Test Guide
Federal Register notice: FDA makes available a final guidance entitled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices.” 02/01/2019

Guide on Device Safety/Performance-based Pathway
Federal Register notice: FDA issues a guidance, Safety and Performance Based Pathway, that discusses the agency’s current thinking on expanding the concept of the abbreviated 510(k) program for demonstrating substantial equivalence for 510(k) submissions. 02/01/2019

Guide on REMS Survey Methodologies
Federal Register notice: FDA releases a draft guidance entitled Survey Methodologies to Assess REMS Goals That Relate to Knowledge that gives information to industry on conducting REMS assessment surveys. 02/01/2019

Draft Guide on Drug Marketing Status Notifications
Federal Register notice: FDA makes available a draft guidance entitled “Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format.” 01/31/2019

Neurological Devices Panel Meeting on Alzheimer’s Device
Federal Register notice: FDA announces a 3/21 Neurological Devices Panel of the Medical Devices Advisory Committee meeting that will review a de novo request for the NeuroAD Therapy System for Alzheimer’s dementia. 01/31/2019

Panel to Review Pre-Pen Plus Skin Test
Federal Register notice: FDA announces a 3/27 Pulmonary-Allergy Drugs Advisory Committee meeting. to discuss a AllerQuest NDA for Pre-Pen Plus, a skin-test kit for determining sensitization to penicillin. 01/31/2019

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