Drugs
DEVICES FDA has approved an Abiomed PMA for its Impella 2.5, Impella CP, Impella 5.0 and Impella LD heart pumps to provide treatment of ongoing cardiogenic shock. “In this setting, the Impella heart pumps stabilize the patient’s hemodynamics, unload the left ventricle, perfuse the end organs and
Drugs
Congressman Ted W. Lieu (D-CA) has introduced two bills that would place additional requirements on medical device makers when they make certain changes to their devices. The bills are in response to a yearlong investigation he requested by the House Committee on Oversight and Government Reform that found significant
Drugs
Total prescription drug spending in the U.S. reached $310 billion in 2015, up 8.5% from the previous year, according to a new report by IMS Institute for Healthcare Informatics. “The savings from branded medicines facing generic competition were relatively low in 2015, and the impact of price increases
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Data Integrity and Compliance With CGMP. It purpose is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs and is in response to an increase in CGMP violations involving data integrity
FDA Policy/General
Federal Register Notice: FDA’s Antimicrobial Drugs Advisory Committee will meet 6/9, from 8:30 a.m. to 5 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will discuss a Merck BLA
FDA Policy/General
Federal Register Notice: FDA will hold a meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee 6/2-3, from 8 a.m. to 6 p.m. at the Hilton Washington DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD. The committee will discuss recent
FDA Policy/General
Federal Register Notice: FDA is correcting a 3/10/14 Federal Register notice that withdrew approval of 8 NDAs and 46 ANDAs for prescription pain medications containing propoxyphene from multiple applicants. The document failed to withdraw approval of an Xanodyne Pharmaceuticals NDA 017507 for Darvocet-N 100 (propoxyphene napsylate and
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Eli Lilly’s Cyramza (ramucirumab) is 3,521 days for extending a patent which claims the human biological product. Cyramza is indicated for treating gastric cancer. To view this notice, click here.
FDA Policy/General
FDA has granted approval to Redwood City, CA-based Nevro Corp. for surgical leads that are specifically designed for use with the Senza Spinal Cord Stimulation (SCS) System delivering HF10 therapy for chronic leg and back pain. The company says its HF10 therapy delivers electrical pulses to the spinal cord
FDA Policy/General
Federal Register Notice: FDA is making available additional draft and revised draft product-specific bioequivalence (BE) recommendations on the design of BE studies to support ANDAs. These products include: albendazole, amlodipine besylate, betamethasone dipropionate, eluxadoline, and lenvatinib mesylate. To view this notice, click here.
Drugs
Eight days after its 510(k) was cleared, Philadelphia heart surgeon and power morcellation activist Hooman Noorchashm has filed a petition to FDA seeking the immediate reclassification of Advanced Surgical Concepts’ Pneumoliner power morcellation tissue containment device. The petition asks commissioner Robert Califf to require the device to meet premarket
Drugs
The Generic Pharmaceutical Association (GPhA) says that FDA should deny a 12/16/15 AbbVie petition asking the agency to require specific criteria before designating any product as an interchangeable biologic. AbbVie had called on FDA to require: that interchangeability be established in each condition of use for which the
Devices
CDRH has released a guidance on “Radiation Biodosimetry Medical Countermeasure Devices” that provides recommendations on the information that should be submitted to support marketing authorization for devices intended to measure biological responses to unintended (non-therapeutic) radiation absorption. Biodosimetry devices are used for reconstructing the ionizing radiation dose received by
FDA Policy/General
Federal Register Notice: FDA is soliciting information on issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying system attributes that are necessary to implement the requirements established under the Drug Supply Chain Security Act (DSCSA). The information gathered from
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Center for Devices and Radiological Health Appeals Processes,” 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.
Devices
FDA has cleared a Trividia Health 510(k) for its True Metrix Go Self-Monitoring blood glucose system. The device includes a meter that twists on to a vial of True Metrix test strips that consolidate, with a mini lancer, into a compact, all-in-one blood glucose system that
FDA Policy/General
A House appropriations subcommittee has approved a 2017 funding bill that would provide FDA $2.7 billion in discretionary spending, a $33 million (1%) increase over fiscal year 2016 spending levels. Including revenue from user fees, total 2017 funding is $4.78 billion – $97.4 million (2%) more than 2016.
Drugs
An Unger Consulting review of Warning Letter trends in the first half of FY 2016 finds that FDA is continuing an “intense focus” on compounding pharmacies and outsourcing facilities, which received more than half of the Warning Letters. The analysis asks whether the focus on compounding pharmacies and outsourcing facilities
FDA Policy/General
Federal Register Notice: FDA is extending the comment period for a 3/14 Federal Register notice that requested comments on the Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning Investigational Use of Oxitec OX513A Mosquitoes. The agency is taking this action in response to requests for an
Drugs
FDA has accepted a Bristol-Myers Squibb supplemental BLA for Opdivo that seeks approval for an expanded use in patients with classical Hodgkin lymphoma (cHL) after prior therapies. The application includes data from the company’s CheckMate-205 study, which evaluated the drug in cHL patients who have received an
Devices
Rep. Michael Fitzpatrick (R-PA) is asking Vice President Joe Biden to include in his “Cancer Moonshot” initiative steps to improve medical device reporting to FDA. In a 4/13 letter to Biden, Fitzpatrick raises the issue of the controversial laparoscopic power morcellator that he says “proved tragically unsafe, spread
Drugs
Repros Therapeutics says new Phase 2 clinical data show that vaginal administration of Proellex at doses of both 6 and 12 mg achieved significant reduction in excessive menstrual bleeding, a key symptom of uterine fibroids. “When a sufficient concentration of Proellex is achieved in circulation, amenorrhea (cessation of menses) is