Devices
FDA says that a 12/12-12/16/16 San Francisco District Office inspection at Steiner Biotechnology, Henderson, NV, found objectionable conditions in the firm’s role as sponsor-investigator in significant risk clinical studies of Ridge Graft and Skeletal Graft. According to a just-released 6/21 Warning Letter,
Devices
A 9/6-9/27/Entellus Medical, Plymouth, MN, found “objectionable activities” in the firm’s role as sponsor of a significant risk study of the XprESS Multi-Sinus Dilation System and the Path Assist Confirmation Tools conducted under an IDE, according to a just-released 4/6 Warning Letter.
Drugs
Nizoral Not Withdrawn Due to Safety/Effectiveness: FDA Federal Register notice: FDA determines that Janssen Research & Development“ Nizoral (ketoconazole) tablets, 200 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. 09/01/2017 Guide on Medical Device Panel Meetings Federal Register notice: FDA announces the
FDA Policy/General
Federal Register notice: FDA has determined that Janssen Research & Development’s Nizoral (ketoconazole) tablets, 200 mg, were not withdrawn from sale for reasons of safety or effectiveness. The determination allows FDA to continue to approve ANDAs that reference Nizoral, indicated for treating the following systemic fungal infections in patients
Drugs
FDA has given Pfizer’s Mylotarg (gemtuzumab ozogamicin) a new lifeline with an approval for the once-withdrawn drug for treating adults with newly diagnosed acute myeloid leukemia (AML) whose tumors express the CD33 antigen (CD33-positive AML). The agency also approved Mylotarg for patients aged 2 years and older
FDA Policy/General
Federal Register notice: FDA has announced the availability of a guidance entitled “Procedures for Meetings of the Medical Devices Advisory Committee.” The guidance is intended to provide additional information on the processes for meetings of the Medical Devices Advisory Committee panels other than the Medical Devices Dispute Resolution Panel. It
FDA Policy/General
FDA has released a draft guidance on “Providing Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies (REMS) Document Using Structured Product Labeling Under section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)(21 U.S.C. 9 379k-1(
Devices
An FDA safety alert warns medical professionals to not use alcohol pads or benzalkonium chloride antiseptic towelettes made by China-based Foshan Flying Medical Products Co. due to a lack of sterility assurance and other quality issues. The products are distributed by Total Resources International, Walnut, CA, and Simple Diagnostics
Drugs
FDA, National Cancer Institute and the Society of Urologic Oncology are holding a public workshop 11/28 to improve the conduct of adjuvant clinical trials in bladder cancer and kidney cancer by harmonizing definitions and management of disease recurrence. Currently, no standard definition of disease recurrence is used in these
Devices
FDA has cleared a GE Healthcare 510(k) for the Senographe Pristina with Self-Compression, the first 2D digital mammography system that allows patients to increase or decrease the amount of compression applied to their breast before the mammogram x-ray is taken. The device has a handheld wireless remote
Drugs
CDER has published a new Manual of Policies and Procedures on “Filing Review of Abbreviated New Drug Applications.” The document outlines policies and procedures for conducting an ANDA filing review by the Office of Generic Drugs Division of Filing Review (DFR). It includes DFR reviewer responsibilities when determining whether an
FDA Policy/General
Federal Register notice: FDA has announced the end of support for Version 1.2 of Clinical Data Interchange Standards Consortium Study Data Tabulation Model (SDTM) and an update to the FDA Data Standards Catalog. The agency will continue to support of the newer SDTM Version 1.3 and Version 1.
Devices
FDA has issued a finalized guidance, Procedures for Meetings of the Medical Devices Advisory Committee, with information on the processes for meetings of the various Medical Devices Advisory Committee panels, other than the dispute resolutions panel. A draft of the guidance was issued 4/1/15. It supersedes a 7/
Devices
Two CDRH Division of Cardiovascular Devices staffers say the Center’s early feasibility study (EFS) program worked well for the Bio2 Medical Angel Catheter, which was one of the studies included in the EFS pilot. Writing in the Journal of Vascular Interventional Radiology, the two say an EFS is a
Drugs
FDA is stepping up its safety surveillance on PD-1/PD-L1 inhibitors after an investigational clinical trial involving Merck’s Keytruda (pembrolizumab) in combination with other therapies in multiple myeloma patients “found an excess of deaths for patients receiving Keytruda when combined with these other drugs,” CDER director Janet
Drugs
Charleston Laboratories says it has reacquired all U.S. rights to develop and commercialize its hydrocodone pipeline products from Daiichi Sankyo, ending a three-year collaboration. Charleston says it is centralizing its comprehensive acute pain portfolio and accelerating the process to bring its CL-108 (hydrocodone, acetaminophen, promethazine), an investigational
Drugs
Sunovion Pharmaceuticals has submitted an NDA for dasotraline, an investigational, dual-acting dopamine and norepinephrine reuptake inhibitor for treating children, adolescents and adults with attention deficit hyperactivity disorder (ADHD). The submission is supported by data from the company’s clinical program that included four placebo-controlled safety and efficacy studies,
Drugs
FDA commissioner Scott Gottlieb says CDER and the Office of Regulatory Affairs (ORA) are implementing a “new, historic concept of operations agreement to more fully integrate the drug review programs with the facility evaluations and inspections for human drugs. This new collaboration is a model for how we’ll modernize
Drugs
Pfizer’s Hospira unit is recalling one lot pf vancomycin hydrochloride for injection, 750 mg/vial, following a confirmed customer report of the presence of particulate matter, confirmed as glass, in one vial. A Hospira notice published by FDA says the company has not receive reports of any adverse events
FDA Policy/General
Federal Register notice: FDA has announced support for the most current version of the Medical Dictionary for Regulatory Activities (MedDRA), the end of support for earlier versions of MedDRA, and an update to the FDA Data Standards Catalog for study data provided in regulatory submissions. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has determined that Teva’s Cenestin (estrogens, conjugated synthetic A) tablets, 0.3 milligrams (mg), 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg, were not withdrawn from sale for reasons of safety or effectiveness. The determination allows the agency to approve
Devices
Spectranetics has recalled its Bridge Occlusion Balloon due to the potential for a blocked guidewire lumen. The device is indicated for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. To date, Spectranetics has received nine customer complaints, none of which