Drugs

Latest Federal Register Notices

3 Public Meetings on Drug Distribution
Federal Register notice: FDA announces three public meetings entitled “Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act.” 07/21/2017

Comments on Unapproved Animal Drugs for Minor Species Listing
Federal Register notice: FDA seeks comments on an information collection extension on its “Index of Legally Marketed Unapproved New Animal Drugs for Minor Species — 21 CFR part 516.” 07/21/2017

Comments Sought on Animal Drug Fee Cover Sheet
Federal Register notice: FDA seeks comments on an information collection extension for “Animal Drug User Fee Cover Sheet.” 07/20/2017

Public Meeting on Hereditary Angioedema Drug Development
Federal Register notice: FDA announces a 9/25 public meeting on “Patient-Focused Drug Development for Hereditary Angioedema.” 07/20/2017

Pilot Program on Pharmaceutical Supply Chain Security
Federal Register notice: FDA announces a pilot project program under the Drug Supply Chain Security Act to assist in developing an electronic, interoperable system that will identify and trace certain prescription drugs as they are distributed within the U.S. 07/20/2017

Comments Sought on Animal Drug User Fee Waivers
Federal Register notice: FDA seeks comments on an information collection extension for a guidance on “Animal Drug User Fees and Fee Waivers and Reductions.” 07/20/2017

Comments Sought on ICH Clinical Practice Guide
Federal Register notice: FDA seeks comments on a new information collection associated with “Guidance on E6 (R2) Good Clinical Practice; International Council for Harmonization (ICH)” that amends an ICH guidance entitled ‘‘E6 Good Clinical Practice: Consolidated Guidance’’ (issued in 1996). 07/19/2017

Comments Sought on DTC Studies
Federal Register notice: FDA seeks comments on proposed studies on “Character Space-Limited Online Prescription Drug Communications.” 07/19/2017

Comments Sought on Biologic Adverse Event Reporting
Federal Register notice: FDA seeks comments on an information collection extension for “Adverse Experience Reporting for Licensed Biological Products; and General Records — 21 CFR Part 600.” 07/18/2017

Comments Sought on Combination Product Guidance
Federal Register notice: FDA seeks comments on a new information collection related to a “Draft Guidance for Industry — How To Prepare a Pre-Request for Designation” that outlines requests for feedback from the Office of Combination Products on whether a medical product will be regulated as a drug, a device, a biologic, or a combination product. 07/18/2017

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