Devices
CDRH says its “de novo” medical device clearance program will need more resources under the next user fee reauthorization period in order to operate efficiently. According to meeting minutes from an FDA/industry user fee reauthorization negotiation meeting last month, CDRH officials said the program has been increasing and performance
Drugs
University of Pittsburgh researcher Kenneth Walker has entered into a voluntary settlement agreement with HHS’ Office of Research Integrity (ORI) due to “research misconduct” associated with work supported by the National Institute of Diabetes and Digestive and Kidney Diseases. ORI found that Walker engaged in research misconduct by falsifying and
Drugs
FDA has approved an expanded label for Janssen’s Imbruvica (ibrutinib) based on data supporting its use in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The approved label now includes overall survival data from the Phase 3 RESONATE-2 (PCYC-1115) trial in treatment-naïve CLL/SLL
Drugs
PharMEDium Services has recalled sterile preparations compounded with a single recalled lot of Fresenius’ Kabi Sensorcaine-MPF (bupivacaine HCl). Fresenius Kabi recalled its product due to the presence of particulate matter (glass) that was identified during a reserve sample inspection. The list of affected codes/lots can be found on
Drugs
FDA has approved a Theravance Biopharma supplemental NDA for Vibativ (telavancin) to expand the antibiotic’s label to include data describing the treatment of patients with concurrent Staphylococcus aureus bacteremia in both currently approved indications. Vibativ is approved in the U.S. for treating adult patients with hospital-acquired and
Devices
FDA has cleared an Irvine Scientific 510(k) for expanded use of its Vit Kit vitrification media to include human oocytes. The company says it is the first to obtain such a clearance. Its Vit Kit-Freeze and Vit Kit-Thaw are now intended for use with oocytes, pronuclear zygotes
Devices
FDA has released a draft guidance on “Technical Considerations for Additive Manufactured Devices” that provides regulatory recommendations for device makers using 3-D printing in their manufacturing. The document outlines technical considerations associated with additive manufacturing (AM) processes, and includes recommendations for testing and characterization for devices that include at
FDA Policy/General
DEVICES Biotronik has received FDA approval of Iperia ProMRI HF-T, a cardiac resynchronization defibrillator that provides heart failure patients with access to diagnostic magnetic resonance imaging scans. Iperia devices also have remote monitoring with daily automatic transmission and closed loop stimulation that adapts the heart rate in response to
FDA Policy/General
BIOLOGICS FDA Proposes to Update Biological Standards Federal Register Proposed rule: FDA is proposing to amend the general biological products standards relating to dating periods and also to remove certain standards relating to standard preparations and limits of potency. FDA aims to update outdated requirements, and accommodate new and evolving
Drugs
Members of the FDA Anesthetic and Analgesic Drug Products Advisory Committee voted 16-4 to recommend the safety and efficacy of KemPharm’s Apadaz (benzhydrocodone/acetaminophen oral tablets) for an indication of short-term (up to 14 days) management of acute pain. During the committee meeting, FDA asked the advisors
Drugs
Researchers from many countries say that responding to President Barack Obama’s call to modernize the current regulatory landscape for precision medicine will be no easy task. The worldwide regulatory challenges that arise in response to calls for precision medicine were explored in a 2014 workshop in Hobart, Australia. Information
Drugs
FDA or Congress should develop a true conditional approval system similar to the one operating since 2006 in the European Union, according to Fairleigh Dickinson University executive director of the Rothman Institute of Innovation and Entrepreneurship Joseph Gulfo. Writing in an online Forbes commentary, Gulfo uses a recent advisory committee
FDA Policy/General
Federal Register Notice: The FDA commissioner renews the Pharmacy Compounding Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 4/25/18. To view this notice, click here.
FDA Policy/General
The Senate HELP Committee leadership has written FDA commisioner Robert Califf to communicate concern over the agency’s timeliness in finalizing or withdrawing draft guidance documents. In the 5/6 letter, the lawmakers criticize the agency for leaving companies in the dark to follow draft recommendations for years, “even if
Devices
Medical device companies should move quickly to implement the ISO 13485:2016 quality management standard update, according to consulting firm Emergo. Although the standard has a three-year transition period for compliance with the update, the firm’s online post says that companies would be smart to begin advance planning
Devices
FDA has inexplicably reversed position on its recall of some 2,800 Custom Ultrasonics scope-cleaning machines, according to a Kaiser Health News report. The agency had ordered the equipment off the market 11/2014, saying that Custom repeatedly violated safety laws, increasing the risk of patient infection. The recall
Drugs
FDA has approved a Tolmar Pharmaceuticals NDA supplement to update the label for Eligard (leuprolide acetate for injectable suspension), indicated for the palliative treatment of advanced prostate cancer. The update covers drug stability data that show, prior to mixing, Eligard may be stored at room temperature (59 – 86° F) for
Devices
FDA has cleared a Signostics 510(k) for Uscan, which the company describes as the first smart mobile-connected ultrasound visualization device targeted at urologic care. “Using algorithms from the science of computer vision, Uscan actively recognizes the 3D contours of the bladder, for far more accurate volume measurements than
Drugs
CDER researchers writing in the journal Clinical Cancer Research say that a 9/29/10 agency final rule revising IND safety reporting regulations and guidance did not have the intended effect on the safety reporting practices of commercial sponsors of oncology drug products. More than five years since the final
Drugs
All 30 members of the combined FDA Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted during a 5/3-4 joint meeting to recommend that FDA modify the Risk Evaluation and Mitigation Strategies (REMS) for extended-release and long-acting (ER/LA)
Drugs
FDA has granted an orphan drug designation for Allena Pharmaceuticals’ ALLN-177, oxalate decarboxylase, for treating pediatric hyperoxaluria. The company says that the compound is being developed to treat patients with disorders of oxalate metabolism. There currently are no effective treatments for hyperoxaluria in children, it says, and the orphan
Drugs
To further the possibility of FDA guidance to encourage product sponsors to engage patients throughout the drug research and development lifecycle, the National Health Council and the Genetic Alliance convened a 12/9/15 meeting with 36 stakeholders to inform the scope and content of a proposed FDA guidance document.