Drugs

Latest Federal Register Notices

Workshop on Software Precertification Program
Federal Register notice: FDA announces a 1/30-31/2018 public workshop entitled “Fostering Digital Health Innovation: Developing the Software Precertification Program.” 12/08/2017

Comments Sought on Oncology Center of Excellence Functions
Federal Register notice: FDA announces a 3/15/2018 public meeting entitled “Oncology Center of Excellence: Listening Session.” 12/08/2017

Comments Sought on User Fee Performance Assessment
Federal Register notice: FDA seeks comments on a statement of work to assess current practices when communicating during IND development and identify best practices and areas of improvement. 12/08/2017

FDA Posts Annual Report on Postmarketing Study Requirements
Federal Register notice: FDA posts its annual report on the status of drug/biologic postmarketing requirements and postmarketing commitments. 12/08/2017

Guide on Pediatric Rare Disease Drug Development
Federal Register notice: FDA makes available a draft guidance entitled “Pediatric Rare Diseases — A Collaborative Approach for Drug Development Using Gaucher Disease as a Model.” 12/07/2017

Guide on Serological Tests to Reduce T. Cruzi Infections
Federal Register notice: FDA makes available a guidance entitled “Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components.” 12/06/2017

FDA Comment Period Extended on Reducing Regulation Burdens
Federal Register notice: FDA extends the comment period on a 9/8 notice seeking input on existing regulations and related paperwork requirements that could be modified, repealed, or replaced to achieve meaningful burden reduction. 12/06/2017

FDA Performance Board Members Announced
Federal Register notice: FDA announces the names of the members who will serve on its Performance Review Board. 12/05/2017

Required Notice on Biosimilar Patent Infringement Suit
Federal Register notice: FDA provides notice that an applicant for a proposed biosimilar product notified the agency that a patent infringement action was filed in connection with the applicant’s BLA (AbbVie, Inc., et al. v. Boehringer Ingelheim Intl. GMBH et al). 12/05/2017

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