FDA Policy/General
Federal Register notice: FDA has determined that Eisai’s Belviq and Belviq XR (lorcaserin hydrochloride) tablets were withdrawn from sale for reasons of safety or effectiveness. The determination will prevent any ANDA from being approved that references either product. The drugs are indicated as an adjunct to a reduced-calorie
FDA Policy/General
Federal Register notice: FDA is seeking industry organizations interested in participating in the selection of a nonvoting industry representative to serve on CDRH’s Device Good Manufacturing Practice Advisory Committee. For those interested, a letter stating that interest should be sent to FDA by 4/5. To view the notice,
Devices
Two Morrison & Foerster Life Sciences attorneys say FDA is slowly acting on its commitment to developing a regulatory framework for artificial intelligence/machine learning (AI/ML)-based software as medical devices, but still has not provided any consistent standards. In an online analysis of the agency’s steps, the
Devices
The New Jersey Superior Court has reversed and remanded for new trials two consolidated cases in which plaintiffs sought damages from Ethicon and Bard over pelvic mesh medical devices. The court opinion says the devices were surgically implanted in the female defendants in each case and severe adverse complications ensued
FDA Policy/General
Federal Register notice: FDA is announcing that a collection of information entitled “Obtaining Information to Understand and Challenges and Opportunities Encountered by Compounding Outsourcing Facilities” has been approved by OMB. This is an extension of research that began in 2019. FDA says it has learned about barriers and opportunities encountered
Drugs
FDA has published an immediately effective guidance, Covid-19 Container Closure System and Component Changes: Glass Vials and Stoppers, to collate recommendations for the appropriate reporting category and the content of postapproval change submissions across numerous agency guidances. The document conveys recommendations to holders of NDAs, BLAs, and ANDAs about
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) is planning to study multiple indications in direct-to-consumer (DTC) TV ads. A Federal Register notice says the study “will provide preliminary information on whether consumers face challenges when multiple indications are promoted in a single television advertisement. The study also
Drugs
A New York federal judge has entered an order of permanent injunction sought by FDA against Confidence USA, a Long Island, NY, dietary supplement manufacturer, and the company’s president, Helen Chian, and general manager, Jim Chao. The injunction requires that the company and the two executives stop manufacturing, holding,
Biologics
FDA has accepted for review a Regeneron Pharmaceuticals and Sanofi supplemental BLA for Dupixent (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. Dupixent is currently approved as an add-on treatment for patients with uncontrolled moderate-to-severe asthma
Devices
Taxpayers Protection Alliance senior fellow Ross Marchand says FDA “must reverse its misguided aversion to life-saving coronavirus tests.” Writing online in The Center Square, Marchand praises the approval of three Covid-19 vaccines but says Americans still must make do with a subpar testing regime that takes a day
FDA Policy/General
Federal Register notice: FDA is issuing an order to permanently debarring former Insys vice president Michael Gurry from providing services in any capacity to a person that has an approved or pending drug product application due to his related conviction of a felony. From early 2012 and continuing through 2015,
FDA Policy/General
Federal Register notice: FDA has issued an order permanently debarring Lawrence B. Ryan from providing services in any capacity to a person that has an approved or pending drug product application due to his related conviction of a felony. From 2007 to 2010, Ryan, a physician, authorized drug orders for
Devices
FDA says its review of a Web site maintained by EnMed MicroAnalytics, Charleston, SC, determined that the firm offers Covid-19 blood sample collection kits that are intended for use in the mitigation, prevention, treatment, diagnosis, or cure of Covid-19 in people and thus are legally medical devices. A
FDA Policy/General
Federal Register notice: FDA has announced a publication containing modifications to the list of standards FDA recognizes for use in premarket reviews — Modifications to the List of Recognized Standards, Recognition List Number: 054. The document is intended to assist manufacturers who elect to declare conformity with consensus standards to meet
FDA Policy/General
Federal Register notice: CDER is proposing to refuse to approve a Lexicon Pharmaceuticals NDA for sotagliflozin oral tablets, 200 milligrams (mg) and 400 mg, in its present form. The notice summarizes the grounds for the Center’s proposal and offers Lexicon an opportunity to request a hearing. Sanofi-aventis, Lexicon’
FDA Policy/General
Federal Register notice: FDA has announced a 4/6 Medical Devices Advisory Committee’s Circulatory System Devices Panel meeting. Panel members are scheduled to review a TransMedics PMA for its Organ Care System (OCS) Heart, a portable extracorporeal heart perfusion and monitoring system for the resuscitation, preservation, and assessment of
Drugs
The Government Accountability Office (GAO) says FDA needs to use lessons it has learned during the Covid-19 pandemic to improve its foreign drug inspection program, including efforts to identify alternative mechanisms to satisfy foreign inspection requirements and ways to address its growing backlog of inspections. In testimony prepared for
Devices
FDA says its review of a Web site maintained by Orvic, doing business as Webstore-USAVan Nuys, CA, determined that the firm is marketing an unapproved Covid-19 serology test that is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of Covid-19, and thus is legally
Drugs
An independent data safety monitoring board has recommended that the VIR-7831 arm of the National Institute of Health’s Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV) Phase 3 trial be closed to enrollment due to questions about the magnitude of the drug’s potential benefit. Vir Biotechnology and
Drugs
FDA says it is aware that many patients, families, and others in the amyotrophic lateral sclerosis (ALS) community have had high hopes for BrainStorm Cell Therapeutics’ NurOwn therapy. An agency online notice says that with the recent completion of a Phase 3 trial comparing NurOwn to placebo, “it has become
Drugs
FDA has accepted for priority review an On Target Laboratories NDA for pafolacianine sodium injection as an adjunct for identifying ovarian cancer during surgery. The company says that many cancers, including over 95% of ovarian cancers, over-express folate receptors to enable the uptake of folic acid. Pafolacianine sodium injection
Devices
FDA has cleared an Asensus Surgical 510(k) for the Senhance Surgical System and its use in general surgery procedures. “Senhance goes beyond the typical surgical robotic systems, providing surgical assurance through haptic feedback, eye-tracking camera control, and 3D visualization, and is the first platform to offer 3 mm