Devices
Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) says a 12/2021 FDA Warning Letter to Medtronic “provides an important reminder from FDA as to the correct estimation of risk associated with [medical device] malfunctions.” Writing in his firm’s FDA Law Blog, Shapiro says that among other issues, the letter
Devices
FDA’s latest cybersecurity draft guidance underscores the total product lifecycle nature of cybersecurity considerations for medical devices, including premarket device submissions and deployment mitigations for older legacy devices that were not built with security in mind. That’s the assessment of CDRH Office of Strategic Partnerships and Technology Innovation
FDA Policy/General
Federal Register notice: FDA has announced that it is withdrawing approval of a Secura Bio indication for Copiktra (duvelisib) for treating relapsed or refractory follicular lymphoma. The indication gained accelerated approval 9/2018 and was required to conduct a postmarketing trial to verify the therapy’s clinical benefit. Because the
Biologics
FDA has placed a clinical hold on an Ocugen Phase 2/3 immuno-bridging and broadening study for its Covid-19 vaccine Covaxin (BBV152). “This is a result of the company’s decision to voluntarily implement a temporary pause in dosing participants while it evaluates statements made by the World
Drugs
Just-released FDA Bioresearch Monitoring (BIMO) Program metrics report for fiscal year (FY) 2021 shows substantially fewer clinical investigator (CI) inspections conducted due to Covid-19 travel restrictions. In FY 2019 and before Covid had been detected, CDER conducted 574 CI inspections, but in FY 2021 that number fell to
Devices
The Medical Imaging and Technology Alliance (MITA) says an FDA draft guidance on notifying the agency in advance of a public health emergency about the permanent discontinuance or interruption in manufacturing a device under Section 506J of the Federal Food, Drug, and Cosmetic Act should be “significantly narrower in scope.
Drugs
The Biotechnology Innovation Organization says there are several ways FDA could improve its draft guidance on developing non-opioid analgesics for acute pain. Its recommendations cover considerations for a general acute pain indication, novel mechanism of action, use of FDA expedited programs, FDA-sponsor engagement, chronic pain guidance development, and
Drugs
Myovant Sciences and Pfizer say they have received notice from FDA that it found deficiencies in a supplemental NDA on Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for managing moderate to severe pain associated with endometriosis. The notice said the deficiencies preclude discussion of
Devices
FDA has cleared a Google 510(k) for its Fitbit and the company’s new PPG (photoplethysmography) algorithm to identify atrial fibrillation (AFib). The algorithm is intended to power a new Irregular Heart Rhythm Notifications feature on Fitbit, Google says in a blog post. Often, AFib is difficult to detect
Drugs
Eli Lilly says new data on its investigational monoclonal antibody lebrikizumab show the therapy in combination with standard-of-care topical corticosteroids (TCS) achieved at least 75% improvement in overall disease severity compared to a placebo plus TCS. The company says that the data from its Adhere trial also showed
Drugs
FDA has placed a partial clinical hold on Curis’ TakeAim Lymphoma study, a Phase 1/2 open-label dose escalating clinical trial investigating emavusertib in patients with B-cell malignancies. The company says CDER’s Division of Hematologic Malignancies 2 followed suit by extending a partial hold originally placed by
FDA Policy/General
While removing FDA’s responsibilities for food safety has been kicked around on Capitol Hill for years, a new Politico investigation into CFSAN’s handling of food safety oversight and regulatory activities may draw renewed interest in restructuring the agency to mainly oversee medical products. The investigation examined a number
Devices
FDA says healthcare providers may not be fully aware that the intended use of radiological computer-aided triage and notification (CADt) devices for intracranial large vessel occlusion (LVO) is to triage suspected findings of LVO based on the analysis of brain radiological exams. CDRH is working with LVO CADt device
Drugs
Vanda Pharmaceuticals 4/6 filed a lawsuit in the DC District Court that seeks to compel FDA to produce drug review records under the Freedom of Information Act (FOIA) associated with the company’s supplemental NDA for Hetlioz (tasimelteon) for treating Jet Lag Disorder (JLD) that was given a complete
Drugs
FDA has lifted a Gilead Sciences partial clinical hold earlier placed on studies evaluating its investigational agent magrolimab in combination with azacytidine in myelodysplastic syndrome and acute myeloid leukemia patients. The agency removed the hold after reviewing the comprehensive safety data from each trial, according to the company. Gilead says
FDA Policy/General
2 Device Guides on Performance Criteria 04/08/2022 Federal Register notice: FDA has made available two guidance documents for the Safety and Performance Based Pathway. The first is entitled “Surgical Sutures — Performance Criteria for Safety and Performance Based Pathway” and the other is “Orthopedic Fracture Fixation Plates — Performance Criteria
FDA Policy/General
DEVICES St. Jude Medical has gained PMA approval for the Infinity Deep Brain Stimulation (DBS) system and its DBS directional leads, which the company describes as the first directional lead approved in the U.S. The device is intended to treat two of the most common movement disorders — Parkinson’s
FDA Policy/General
Varian has acquired privately-held Montreal-based Evinance Innovation, Inc., a clinical decision support software company. The acquisition is expected to expand the capabilities of Varian’s 360 Oncology care management platform by integrating clinical workflow, decision support, and adherence tracking based on leading cancer care guidelines. Merck has agreed
FDA Policy/General
Federal Register notice: FDA has made available two guidance documents for the Safety and Performance Based Pathway. The first is entitled “Surgical Sutures — Performance Criteria for Safety and Performance Based Pathway” and the other is “Orthopedic Fracture Fixation Plates — Performance Criteria for Safety and Performance Based Pathway.” To view the
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “E8(R1) General Considerations for Clinical Studies.” The International Council for Harmonization document describes internationally accepted principles and practices for the design and conduct of drug/biologic clinical studies. It also provides an overview of the types of clinical
FDA Policy/General
Federal Register notice: FDA has announced a 5/11-12 Pediatric Oncology Subcommittee meeting. On 5/11, panel members will discuss the development of a conceptual framework that will guide FDA decisions on sponsor plans and requests for waivers of early pediatric investigations of molecularly targeted cancer drugs/biologics when
Devices
FDA says Medtronic has recalled certain MiniMed 630G insulin pumps with SmartGuard due to a labeling design error. The pumps are intended for continuous delivery of basal insulin (at user selected rates) and administration of insulin boluses (in user selectable amounts) for managing Type 1 diabetes mellitus in patients 16