Drugs

Latest Federal Register Notices

Guide on Index of Unapproved New Animal Drugs
Federal Register notice: FDA makes available a draft guidance #210 entitled “The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.” 09/22/2017

PMA Summaries Available for CBER-approved Products
Federal Register notice: FDA makes available the safety and effectiveness summaries of recent PMAs approved by CBER. 09/22/2017

Drug/Biologic User Fees for FY 2018
Federal Register notice: FDA announces the rates for prescription drug user fees for fiscal year 2018. 09/21/2017

Biosimilar User Fee Rates for FY 2018
Federal Register notice: FDA announces rates for biosimilar user fees for fiscal year 2018. 09/21/2017

Draft Guide on Microdose Radiopharmaceutical Diagnostic Drugs
Federal Register notice: FDA makes available a draft guidance entitled “Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations.” 09/20/2017

PMA Critical to Quality Pilot Program
Federal Register notice: FDA announces a “Premarket Approval Application Critical to Quality” pilot program. 09/19/2017

Comment Period Extended on Scheduling Changes to 17 Drugs
Federal Register notice: FDA extends until 9/20 the comment period for an 8/14 Federal Register notice requesting feedback about abuse potential, actual abus, and impact of scheduling changes on 17 drug substances. 09/19/2017

FDA Guide on Device Study Reporting of Age, Race Data
Federal Register notice: FDA makes available a guidance entitled “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies.” 09/19/2017

Vaccines Panel To Discuss 2018 Flu Vaccine
Federal Register notice: FDA announces a 10/4 Vaccines and Related Biological Products Advisory Committee meeting. 09/18/2017

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