Devices
FDA has cleared a Zebra Medical Vision 510(k) for its HealthCXR device intended for use in identifying and triaging pleural effusion in Chest X-rays. The device automatically identifies findings that suggest pleural effusion based on scans, and notifies radiologists, the company says. Pleural effusion is an abnormal accumulation
Devices
FDA says B. Braun has recalled 22 lots of blood administration sets. The recall is due to potential for leakage at the joint between the blood filters and tubing, an FDA statement says. The agency says the recalled sets are used to administer blood from a container to a patient’
FDA Policy/General
The Justice Department says that a Puerto Rico federal grand jury has returned an indictment against Rubén Vázquez-Diaz, charging him with three counts each of introducing misbranded animal drugs, introducing adulterated animal drugs, mail fraud, and wire fraud, and one count of being a drug user in possession of
Drugs
Attorney Joanna Hawana (Mintz) says in an online post that three FDA 11/15 public announcements give the first definitive statements about how the agency intends to apply its existing authorities to cannabidiol and other unapproved cannabis-derived ingredients. The announcements were: * a media statement on Warning Letters issued to
Drugs
FDA has denied without comment a 7/1 US WorldMeds petition asking that the agency: * require any ANDA referencing the company’s Apokyn (apomorphine hydrochloride) injection to seek approval of both the drug and medical device constituent parts of Apokyn; and * establish a policy framework clarifying the circumstances, if any,
Biologics
FDA has ordered Gynecology, Reproductive Endocrinology and Fertility Institute in San Juan, Puerto Rico, and its medical director/owner to immediately cease manufacturing due to significant violations of FDA regulations. An agency statement says an inspection and record review revealed significant violations of regulations on donor eligibility determinations, including donor
Drugs
Evofem Biosciences has resubmitted its NDA for Amphora (L-lactic acid, citric acid and potassium bitartrate), a multipurpose vaginal pH regulator for preventing pregnancy. The submission includes full results from the Phase 3 AMPOWER study, a confirmatory single-arm, open-label Phase 3 trial evaluating the safety and efficacy of
Drugs
The Justice Department says that Heather Alfonso, who worked as an advanced practice registered nurse in a Connecticut pain management center, has been sentenced by a Connecticut federal judge to three years of probation for engaging in a kickback scheme related to fentanyl spray prescriptions. A department statement says that
Devices
Former FDA commissioner Frank Young died 11/24 at age 88. Young served as commissioner from 1984 to 1989. During his time in office, Young led the agency over several major events, including the Hatch-Waxman Drug Price Competition and Patent Term Restoration Act (1984), and passage of the Prescription
Drugs
A 3/12-3/22 FDA inspection at the Lohxa drug manufacturing facility in Worcester, MA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 9/10 Warning Letter says specific violations were: * failing to establish and follow an adequate written testing program
Devices
A report from the Center for Disease Control and Prevention’s National Healthcare Safety Network says that healthcare-associated infections related to the use of medical devices are more likely to be antibiotic resistant than infections resulting from surgical procedures. The report was published in the Society of Healthcare Epidemiology’
Drugs
CymaBay Therapeutics has terminated a Phase 2b study of seladelpar in subjects with non-alcoholic steatohepatitis and its recently initiated Phase 2 study of seladelpar in subjects with primary sclerosing cholangitis due to safety concerns. In addition, the company is putting on hold all studies of seladelpar in subjects with
FDA Policy/General
Federal Register notice: CDRH has announced an Ethylene Oxide Sterilization Master File Pilot Program that will allow sterilization providers that sterilize single-use medical devices using fixed chamber ethylene oxide (EtO) to submit a master file when making certain changes between sterilization sites or when making certain changes to sterilization
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products.” The document describes FDA’s compliance policy for premarket review requirements for two types of limited modifications to new tobacco products that were on the market as of 8/8/
Devices
FDA has approved a Tusker Medical PMA for the Tubes Under Local Anesthesia System for delivery of tympanostomy tubes (ear tubes) that can be inserted into the eardrum to treat recurrent ear infections (i.e., otitis media). An FDA release says this is the first ear tube delivery system that
Drugs
Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) have released their ideas for Cures 2.0 legislation to update the 21st Century Cures Act. Upton and DeGette say (contains link to Cures 2.0 document) they are looking for feedback on their proposal and new ideas to consider
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. EPH Technologies, Silver Spring, MD (11/18): After reviewing company-operated Web sites, FDA determined that its Detoxoplex, Sinoplex and Migrenza products are unapproved new drugs. For example, Detoxoplex
FDA Policy/General
The Alliance for a Stronger FDA says consideration should be given to FDA staff as we sit down for Thanksgiving dinner this week. “ Consider adding thanks to FDA and its devoted staff, including the inspectors who never get sufficient credit for the difficulty and potential danger in their jobs,” the
Drugs
University of Tokyo researchers say the quality of adverse event reports submitted to FDA seems to depend on information costs accrued to potential reporters. They found that the completeness of reports from consumers was generally greater than that of reports from healthcare professionals. “Completeness of specific items varied among different
Drugs
Teva and other generic drug companies have held talks with the federal government over the last six months in an attempt to resolve a long-running criminal antitrust investigation into alleged price-fixing. Bloomberg News reports it has learned from sources familiar with the matter that among the possible outcomes
Drugs
Spherix Global Insights says that approval of a new indication for Janssen’s Invokana, a sodium-glucose co-transporter 2 inhibitor, could lead to a paradigm shift in the way patients with Type 2 diabetes and chronic kidney disease are treated in the future. Invokana was approved to treat Type
FDA Policy/General
FDA has named Kaveeta Vasisht as associate commissioner for women’s health. The announcement says she joined the Office of Women’s Health earlier this year and has been the acting associate commissioner and deputy director for the past nine months. Trained as both a physician and a pharmacist, Visisht