Drugs
FDA has granted accelerated approval to Janssen Biotech’s Darzalex Faspro (daratumumab plus hyaluronidase) for combination use with bortezomib, cyclophosphamide and dexamethasone for newly diagnosed light chain amyloidosis. The approval was based on data from the ANDROMEDA (NCT03201965) trial in 388 patients with measurable disease and at least one affected
Drugs
FDA has approved a Daiichi Sankyo BLA for Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. Approval was based on data from the DESTINY-Gastric01 (NCT03329690) trial in patients with
Devices
FDA has cleared a DePuy Synthes 510(k) for the Velys Robotic-Assisted Solution and its use with the Attune Total Knee System. The robotic device is designed to adapt to the “surgeon’s workflow, and is designed to give them the control they are used to and helps them
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Bodyhealth.com, Clearwater, FL (12/9/2020) An FDA review of the company’s Web site (www.bodyhealth.com) has determined that
Biologics
U.S. Stem Cell, Inc., Sunrise, FL, says it argued 1/13 before the 11th Circuit Court of Appeals that it should be allowed to present evidence and testimony in support of its position and practices in a trial. The case involves a 5/9/18 FDA suit against the
Biologics
FDA has accepted for priority review an Omeros BLA for narsoplimab for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). HSCT-TMA is a significant and often lethal complication of stem cell transplantation. “This condition is a systemic, multifactorial disorder caused by endothelial cell damage induced by conditioning
Devices
FDA has given PMA approval for Seno Medical Instruments’ diagnostic breast cancer imaging technology that the company says helps doctors better differentiate between benign and malignant breast lesions. Seno says its Imagio breast imaging system uses non-invasive opto-acoustic ultrasound technology to provide real-time information on suspicious breast
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Data to Support Drug Product Communications as Used by the Food and Drug Administration,” (OMB Control Number 0910–0695). The collection supports agency outreach efforts, such as testing of communication messages in advance of a communication campaign.
FDA Policy/General
Three staff in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine of the University of Pennsylvania say FDA “cannot make decisions on the basis of science alone, and political considerations sometimes do have a role to play.” In an online letter to the editor
FDA Policy/General
In an interview less than 24 hours before he leaves office with the change in presidential administrations, FDA commissioner Stephen Hahn has acknowledged significant pressure from the White House over Covid-19 vaccines and treatments. “I heard loud and clear from the White House, President Donald Trump, and others, that
Drugs
FDA has issued an immediately-in-effect guidance, Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency, to alert drug manufacturers and pharmacists who engage in drug compounding to the potential public health hazard of alcohol (ethyl alcohol or ethanol) or isopropyl
FDA Policy/General
20 Drug Determinations on ANDA Availability Federal Register notice: FDA has determined that 20 drug products (detailed below) were not withdrawn from sale for reasons of safety or effectiveness. The determination means that the agency will continue to approve ANDAs that refer to the products as long as they meet
FDA Policy/General
Federal Register notice: FDA has rescheduled a public meeting for 2/12 on “Patient-Focused Drug Development for Vitiligo,” which was originally scheduled to occur 3/30/2020. The meeting is intended to obtain patient perspectives on the impact of vitiligo on daily life, patient views on treatment approaches, and
FDA Policy/General
Federal Register notice: FDA has announced a 4/7 virtual public meeting entitled “Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.” The meeting is intended to fulfill an FDA user fee agreement commitment to seek stakeholder input about data standards and the electronic submission system’s
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 27 ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed and requested that they be withdrawn. To view the notice, click here.
Drugs
FDA has made available a new guidance entitled Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the Covid-19 Public Health Emergency. The document is intended to assist prospective ANDA applicants in ensuring the protection of participants when resuming or initiating bioequivalence (BE) studies conducted to support
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection entitled “Survey of Drug Product Manufacturing, Processing, and Packing Facilities — 21 CFR parts 210 and 211.” The collection is intended to examine industry-wide data on how facilities that manufacture, process, and pack drug products for use in humans
Drugs
An FDA inspection last month at Lonza’s Viral Vector contract-manufacturing facility in Houston, TX, resulted in a four-item FDA-483, but more importantly it released an FDA review hold on a Bristol-Myers Squibb (BMS) BLA for lisocabtagene maraleucel (liso-cel), indicated for treating adults with relapsed
Drugs
FDA is alerting health care professionals about labeling updates for the preparation of vinca alkaloids, a group of chemotherapy agents that includes vincristine sulfate injection, vinblastine sulfate injection, and vinorelbine tartrate injection. To reduce the potential for unintended intrathecal (spinal) administration, which causes death or severe neurological injury, the agency
FDA Policy/General
Former FDA commissioner David Kessler has been selected by the incoming Biden Administration to lead the U.S. Covid-19 vaccination efforts — replacing Operation Warp Speed head Moncef Slaoui, who is resigning at the Biden transition team’s request. The Operation Warp Speed moniker is also being changed to “Covid
FDA Policy/General
FDA Webview’s newsroom will be closed Monday (1/18) in observance of Martin Luther King day. Nightly emails will resume 1/19.
Devices
FDA has announced the unsealing of an indictment charging two former Michigan-based Beaumont Hospital employees and a medical supply distributor with wire fraud based on their scheme to steal medical devices from the hospital and then sell them on the Internet. Charged were: Paul Purdy, 49, of Beavercreek, OH;