Drugs

Latest Federal Register Notices

FDA Extends Deadline for Lab Test Identifiers in Applications
Federal Register notice: FDA announces an extension of the deadline to provide Logical Observation Identifiers Names and Codes for clinical laboratory test results in investigational study data provided in regulatory submissions submitted to CDER and CBER. 10/20/2017

Class 2 for Microbial Pathogen Detectors In Cerebrospinal Fluid
Federal Register notice: FDA classifies devices that detect and identify microbial pathogen nucleic acids in cerebrospinal fluid into class 2 (special controls). 10/20/2017

Draft Guide on Generic Tiotropium Bromide Products
Federal Register notice: FDA makes available a draft guidance for industry on generic tiotropium bromide inhalation powder. 10/20/2017

3 Draft Guides on Generic Inhalation Drugs
Federal Register notice: FDA makes available three draft guidances for industry on generic salmeterol xinafoate inhalation powder, fluticasone propionate inhalation aerosol, and fluticasone propionate inhalation powder. 10/20/2017

CDRH Seeks Experiential Learning Partners
Federal Register notice: CDRH announces its 2018 Experiential Learning Program. 10/18/2017

Class 2 Designation for Organophosphate Test System
Federal Register notice: FDA classifies the organophosphate test system into Class 2 (special controls). 10/18/2017

Comments Sought on Device Tracking Collection
Federal Register notice: FDA seeks comments on an information collection extension request for “Medical Devices; Device Tracking — 21 CFR Part 821.” 10/18/2017

Certain Devices for Detecting Microbial Pathogens into Class 2
Federal Register notice: FDA classifies nucleic acid-based devices for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens into Class 2 (special controls). 10/17/2017

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