Devices
An Abbott PMA for the first fully absorbable drug eluting stent contains clinical data showing the device was not inferior to a traditional stent, according to an FDA briefing document released in advance of a 3/15 Circulatory System Devices Panel meeting. While clinical data for Abbott’s Absorb GT1
Drugs
Cancer therapies are reaping rewards under FDA’s breakthrough therapy program. According to a new analysis released by Friends of Cancer Research (FOCR), drugs with breakthrough designations gained approval more quickly than those without the designation and they experienced faster pre-market development and review times. “We also found that
Devices
A new Harvard analysis lends support to recent bills introduced in the House and Senate that propose shorter “pre-market” clinical testing and better “post-market” surveillance than current standards for certain devices. The analysis is limited to coronary stents, and the researchers note their theoretical model “provides guidance on
Devices
CDRH is escalating its enforcement against laboratory-developed tests being marketed for Zika virus detection. Last week, the Center sent a letter to MD Biosciences challenging its marketing of the Zika Virus RNA by RTPCR Assay (see story). Now, the agency has sent two additional letters — one to First Diagnostic
Biologics
FDA’s costs for implementing its biosimilars program jumped almost 40% last year after the first application was reviewed and approved, according to a new independent report commissioned by the agency. The report was mandated by the biosimilars user fee program to study the workload volume and full costs associated
Drugs
FDA says Gilead Sciences has confirmed that they are stopping six clinical trials involving Zydelig (idelalisib) in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma and indolent non-Hodgkin lymphomas due to reports of deaths and increased rates of adverse events. Last week, the agency said it was evaluating the
FDA Policy/General
Federal Register Notice: FDA is making available for public comment the draft environmental assessment submitted by Oxitec Ltd. and a preliminary finding of no significant impact in support of an investigational release of OX513A Aedes aegypti genetically-engineered mosquitoes under an investigational new animal drug exemption. It is a part
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Implementation of the ‘Deemed to be a License’ Provision of the Biologics Price Competition and Innovation Act of 2009. It describes the agency’s approach to implementing the statutory provision under which an application for a biological
FDA Policy/General
Federal Register Notice: FDA’s Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee will meet 5/3-4 at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committees will
Drugs
Tesaro has submitted an NDA for an intravenous formulation of Varubi (rolapitant), indicated for use in combination with other antiemetic agents in adults for preventing delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. The P/neurokinin-1 receptor antagonist was originally approved in a
FDA Policy/General
DEVICES Becton Dickinson has received FDA approval for its BD Totalys MultiProcessor and BD Totalys SlidePrep instruments for use in cervical cancer screening, as well as providing ancillary testing aliquot capability. FDA has approved Boston Scientific’s Blazer Open-Irrigated radiofrequency ablation catheter to treat Type I atrial flutter, an
FDA Policy/General
BIOLOGICS Guidance on HCT/P Donor Screening to Reduce Zika Virus Federal Register Notice: FDA is making available a document entitled Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry. It provides establishments that
Drugs
New York has reached an agreement with Endo Pharmaceuticals over its marketing of long-acting opioid, Opana ER. The agreement requires Endo to “cease all misrepresentations regarding the properties of Opana ER, to describe accurately the risk of addiction to Opana ER, and to summarize studies regarding Opana ER on
Devices
Teleflex has begun a recall of its Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits because the sheath body may become separated from the sheath hub. If the separation occurs, the patient may bleed from the sheath. Interruption or loss of intra-aortic balloon pump treatment may
Drugs
FDA has given expanded approval to Pfizer’s Xalkori (crizotinib) to treat people with metastatic non-small cell lung cancer (NSCLC) whose tumors have an ROS-1 gene alteration. This gene alteration is present in about 1% of patients with NSCLC. “The overall patient and disease characteristics of NSCLC with
Drugs
FDA says it is evaluating the safety of Gilead Sciences 2014-approved Zydelig (idelalisib), indicated for treating patients with three types of blood cancers, after receiving reports of deaths in clinical trials involving the drug. “The safety of patients is a top priority and the FDA will communicate new safety-
Drugs
A coalition made of 15 public health and patient advocate groups have written Senate lawmakers opposing seven bills that were reported out of the Senate HELP Committee 3/9 (see earlier story). The groups say they are “concerned that the focus of these bills is on getting medical products to
Drugs
CDER has posted a revised internal policy document on “Prioritization of the Review of Original ANDAs, Amendments, and Supplements” that describes the priority certain generic drug applications receive during the review process. According to the document, the following types of submissions receive the highest priority reviews: 1. Submissions containing patent
Drugs
FDA has accepted for review an Amgen supplemental BLA for the expanded use of Enbrel (etanercept) to treat pediatric patients with chronic severe plaque psoriasis. The submission is supported by data from a Phase 3 one-year study and a five-year open-label extension study. The agency has set
Drugs
FDA has posted a draft guidance (XXINSERT LINKXXX) entitled “Deemed to be a License Provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) ” that describes the agency’s approach for transferring protein products that were approved as NDAs to licensed BLAs that adhere to the regulatory
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Guidance for Industry on Individual Patient Expanded Access Applications: Form FDA 3926,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: CDRH will sponsor the 2016 Experiential Learning Program (ELP). The training component is intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, and challenges faced in broader disciplines that impact the device development life cycle. The Center is inviting medical device industry,