FDA Policy/General

Latest Federal Register Notices

Draft Guidances for ANDA Bioequivalence Study Designs
Federal Register notice: FDA announces the availability of additional draft and revised draft product-specific guidances that provide product-specific recommendations on bioequivalence study designs. 07/14/2017

2 Animal Drugs Withdrawn on Sponsor’s Request
Federal Register notice: FDA withdraws approval of two new animal drug applications at the sponsor’s request because these products are no longer manufactured or marketed. 07/12/2017

Comments Sought on Drug CMC Date Elements
Federal Register notice: FDA requests comment on draft standardized Pharmaceutical Quality/Chemistry Manufacturing and Control data elements and terminologies for electronic submission. 07/11/2017

Regulatory Review Period Determination for Intercept Plasma Device
Federal Register notice: FDA determines that the regulatory review period for Cerus Corp.’s Intercept Blood System For Plasma is 6,497 days. 07/11/2017

Regulatory Review Period Determination for Intercept Platelet Device
Federal Register notice: FDA determines that the regulatory review period for Cerus Corp.’s Intercept Blood System for Platelets is 7,080 days. 07/11/2017

1,003 Class 2 Devices Exempted from 510(k)
Federal Register notice: FDA announces a list of 1,003 Class 2 devices that it has determined no longer require premarket notification to provide reasonable assurance of safety and effectiveness. 07/11/2017

Panel to Review Expanded Use for Pfizer’s Xeljanz
Federal Register notice: FDA announces an 8/3 Arthritis Advisory Committee meeting that will review a Pfizer supplemental NDA for Xeljanz (tofacitinib) for treating adult patients with active psoriatic arthritis. 07/10/2017

FDA Files Annual Reports on Closed Panel Meetings
Federal Register notice: FDA files with the Library of Congress annual reports of certain FDA advisory committees that held closed meetings during fiscal year 2016. 07/10/2017

Approved Information Collection Listing
Federal Register notice: FDA publishes a list of information collections that have been approved by the Office of Management and Budget. 07/10/2017

Comments Sought on Safety Communication Surveys
Federal Register notice: FDA seeks comments on an information collection on “FDA Safety Communication Readership Surveys.” 07/10/2017

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