Drugs

Latest Federal Register Notices

Pharmaceutical Quality Site Visit Program
Federal Register notice: CDER announces the Fiscal Year 2019 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. 08/24/2018

Plasma Lyte Not Withdrawn Due to Safety/Efficacy
Federal Register notice: FDA determines that Plasma – Lyte M And Dextrose 5% and Plasma Lyte and Dextrose 5% were not withdrawn for reasons of safety or effectiveness. 08/24/2018

Guide on Hematologic Malignancy and Oncologic Drug Trials
Federal Register notice: FDA makes available a draft guidance entitled “Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development.” 08/24/2018

Info Collection Extension for User Fee Cover Sheet
Federal Register notice: FDA seeks comments on an information collection extension entitled “Prescription Drug User Fee Cover Sheet; Form FDA 3397.” 08/24/2018

Comments Sought on Sunscreen Info Collection
Federal Register notice: FDA seeks comments on an information collection extension entitled “Sun Protection Factor Labeling and Testing Requirements for Over-the-Counter Sunscreen Drug Products.” 08/23/2018

Draft Guide on Osteoarthritis Structural Endpoints
Federal Register notice: FDA makes available a draft guidance entitled “Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and Biological Products for Treatment.” 08/23/2018

Members Sought for Device Advisory Panels
Federal Register notice: FDA requests nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee and device panels of the Medical Devices Advisory Committee. 08/23/2018

Danicrine Not Withdrawn Due to Safety/Efficacy
Federal Register notice: FDA determines that Danocrine (danazol) Capsules, 50mg, 100mg, and 200mg, were not withdrawn from sale for reasons of safety or effectiveness. 08/23/2018

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