Drugs
FDA has approved Genentech’s Rituxan (rituximab) in combination with chemotherapy for pediatric patients with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukemia (B-AL). Approval was based on data from the Inter-
FDA Policy/General
Regulatory Review Period Determined for Dojolvi 12/2/2021 Federal Register news: FDA has determined for patent extension purposes the regulatory review period for Ultragenyx’s Dojolvi (triheptanoin), indicated as a source of calories and fatty acids for treating pediatric and adult patients with molecularly confirmed long-chain fatty acid
FDA Policy/General
DEVICES FDA has cleared a K2M Group Holdings 510(k) for its Ozark Cervical Plate Systems for anterior screw fixation to the cervical spine (C2-T1) in patients with degenerative disease, deformity, tumor, or trauma. The systems are available in two designs, Ozark Guide and Ozark View, both featuring an
FDA Policy/General
Astellas and Anokion will create Kanyos Bio to collaborate on developing new treatments for Type 1 diabetes and celiac disease. DalCor Pharmaceuticals and the Montreal Heart Institute will conduct an international Phase 3 clinical trial seeking to validate the clinical efficacy of dalcetrapib, that according to an MHI published could
FDA Policy/General
Federal Register notice: FDA is requesting nominations for voting members to serve on CDRH’s National Mammography Quality Assurance Advisory Committee. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is classifying the intraoperative orthopedic strain sensor into Class 2 (special controls). The decision is based on an Intellirod Spine de novo classification request for its Loadpro Intraoperative Rod Strain Sensor. The agency has identified it as an adjunct tool intended to measure strain on an
FDA Policy/General
Federal Register notice: FDA is classifying the trunk and limb electrical stimulator to treat headache into Class 2 (special controls). The decision is based on a Theranica Bioelectronics de novo classification request for its Nerivio Migra device. The agency has identified it as a device intended to treat headache through
Drugs
FDA has revised an Eli Lilly emergency use authorization (EUA) for bamlanivimab and etesevimab to be used in younger pediatric patients than previously authorized for treating mild to moderate Covid-19. Previously, the monoclonal antibodies’ combination use was authorized for pediatric patients 12 years of age and older, and the
FDA Policy/General
It appears FDA acting commissioner Janet Woodcock will continue to play a senior role at the agency if FDA commissioner nominee Robert Califf is confirmed by the Senate. Califf reportedly has asked Woodcock to stay on in the Office of the Commissioner, but it is not clear whether he will
Devices
Congress should use the upcoming Cures 2.0 bill draft and the reauthorization of the medical device user fee program to effect meaningful change to the 510(k) clearance process, such as revamping methods used to classify risk, according to an opinion piece appearing online on Statnews.com. The piece
Devices
FDA has launched a new Web page about paclitaxel-coated balloons and paclitaxel-eluting stents that are approved to treat obstructed lesions in arteries of the legs. The page includes information about risks associated with these devices and ongoing agency efforts to work with manufacturers and investigators on additional clinical
Devices
The New Jersey Supreme Court has an opportunity to make a decision that “will have a major impact on medical device liability and, in turn, the availability of important new devices that offer technological advances over previous products.” That’s the position explained by attorney Phil Goldberg (Shook, Hardy &
Drugs
An FDA online consumer post updates agency efforts to provide more drug information to women who are pregnant or breastfeeding. “When a prescription medication is approved by FDA for adults, it is also approved for pregnant patients,” FDA says. “But information about medication dosing during pregnancy and breastfeeding is often
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA draft guidance on investigator responsibilities for safety reporting for investigational drugs and medical devices “will help further ensure a consistent approach to safety and safety reporting throughout the entire medical product development process.” In its 11/29 comment letter, the
Devices
A self-employed medical sales representative will pay $100,000 to settle allegations that he assisted in causing the submission of false claims. A Justice Department statement says Matthew Thibaut, from Cyprus, who sold products through his Flex Surgical Management company, sold DyAnsys electro-acupuncture devices from 1/1/17
FDA Policy/General
Federal Register notice: FDA is classifying the conditioning tool for eating disorders into medical device Class 2 (special controls). The decision was based on a de novo classification request by AB Mando for its Mandometer, a prescription device that is intended to measure the mass of food eaten during a
FDA Policy/General
Federal Register notice: FDA is classifying the esophageal tissue characterization system into Class 2 (special controls). The decision was based on a de novo classification request by Diversatek Healthcare for its Mucosal Integrity Conductivity Test System, intended for use in obtaining measurements of electrical properties within esophageal tissue. To view
Drugs
FDA officials told an 11/30 meeting of the National Industrial Hemp Council that the agency still believes it needs additional CBD (cannabidiol) research and safety data before it can be considered for uses beyond prescription drugs such as a food additive or dietary supplement. CDER deputy director for regulatory
Drugs
The Justice Department says the former chief financial officer and former head of corporate communications for a $21 billion biopharmaceutical company have been arrested for their role in an insider trading scheme. (While the Justice Department statement did not identify the company, the Associated Press reports that a Securities and
Devices
FDA has cleared a CoreLink 510(k) for its CentraFix Midline Spinal Fixation System. The device is a posterior thoracolumbar pedicle screw system designed for use with a medial-to-lateral approach, known as cortical bone trajectory (CBT). “This technique maximizes contact of the pedicle screw with cortical bone and
Devices
FDA has cleared a Sound Life Sciences 510(k) for its sonar software for consumer smart devices. The smartphone app produces inaudible ultrasonic sonar pulses to detect reflections caused by nearby patient respiration, according to the company. The prescription-only application can be used in home or clinical settings to
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of five ANDAs from multiple applicants after they notified the agency that the products are no longer marketed. To view the notice, click here.