FDA Policy/General
SUNSET Rule Effective Date Postponed 03/19/2021 Federal Register notice: HHS is postponing, pending judicial review, the effective date of a final rule entitled “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET final rule) that was published 1/19. The SUNSET final rule was scheduled to take effect 3/
Devices
FDA has announced a 5/4 virtual public meeting entitled “Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices.” Sources of patient generated data, data quality measures, interoperability, and potential impacts of the data in regulatory and healthcare settings will be discussed during the meeting. To
Drugs
FDA has accepted a Bristol Myers Squibb NDA for mavacamten, an investigational allosteric modulator of cardiac myosin for treating patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The agency has set a user fee review action target date of 1/28/2022. The submission was based on data from the pivotal
Biologics
CBER’s Office of Compliance and Biologics Quality has issued Reno Integrative Medical Center an untitled letter after reviewing the institution’s Web site (www.renointegrativemedicalcenter.com) and determining its cancer immunotherapy product is a human cell, tissue, or cellular or tissue-based product requiring an approved BLA. The letter
Drugs
An FDA safety alert advises that health care professionals not use Becton, Dickinson’s ChloraPrep 3 mL applicators due to microbial contamination risks. The affected drug product is labeled “CareFusion, El Paso, TX.” BD’s investigation “confirmed the product’s lid, when exposed to higher temperature and humidity, can fail
FDA Policy/General
Federal Register notice: HHS is postponing, pending judicial review, the effective date of a final rule entitled “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET final rule) that was published 1/19. The SUNSET final rule was scheduled to take effect 3/22. However, on 3/9 a lawsuit was
Drugs
FDA has approved a Janssen NDA for Ponvory (ponesimod), a once-daily oral selective sphingosine-1-phosphate receptor 1 modulator for treating adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. The approval was based on data from a
Drugs
FDA has approved a Kiniksa Pharmaceuticals NDA for Arcalyst (rilonacept) injection to treat recurrent pericarditis and reduce the risk of recurrence in adults and children 12 years and older. Recurrent pericarditis involves inflammation of the pericardium, a thin tissue sac surrounding the heart, which can cause chest pain, an agency
Drugs
FDA acting commissioner Janet Woodcock told an American Medical Association Webinar 3/17 the federal government is no longer distributing Lilly’s monoclonal antibody bamlanivimab in Arizona, California, and Nevada because of the presence of a viral variant that is not susceptible to the drug. Endpoints News reports that Woodcock
FDA Policy/General
Federal Register notice: FDA is amending the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during July, August, and September 2020. FDA is also making available summaries of the basis of approval and environmental review documents, where applicable. To
Drugs
CDER has created a new Web page to house scientific review documents supporting emergency use authorizations (EUAs) for drug and biological therapeutic products, including any amendments. The Center says that the page is intended to “promote public confidence in FDA’s scientific review process” and it is “consistent with our
FDA Policy/General
California attorney general Xavier Becerra was confirmed by the U.S. Senate 3/18 as HHS secretary, a move that could expedite the nomination of an FDA commissioner. The delay in nominating a commissioner has been noteworthy among FDA observers (see earlier story), with many acknowledging that two earlier prospects
Devices
FDA has cleared a Life Spine 510(k) for the Prolift Wedge Expandable Spacer System, described as a lordotic expandable implant for micro-invasive transforaminal lumbar interbody fusion back surgery and posterior lumbar interbody fusion procedures. “The device maintains coronal alignment while achieving sagittal correction through controlled lordotic expansion of
Devices
FDA says a 1/18 recall of the ACIST Kodama intravascular ultrasound catheter due to risk of broken O-ring pieces flushing into arteries during use is Class 1. The device uses ultrasound waves to view the inside of an artery, including its structure, and any devices such as stents.
Drugs
Janssen says long-term data from the Phase 3 DISCOVER-2a study show that the skin clearance, joint symptom relief, and safety of Tremfya (guselkumab), previously seen at 24 and 52 weeks in adults with active psoriatic arthritis, continued through week 112. “These findings also confirmed that the robust efficacy
Drugs
Three students in the Duke Science Regulation Lab, an interdisciplinary course offered through the Duke University law and graduate schools, recommend several steps FDA could take to improve a draft guidance, Investigational New Drug Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations. The comment letter says that
Drugs
GlaxoSmithKline says the first patient has been dosed in its SWIFT-2 trial as part of a Phase 3 clinical program investigating the safety and efficacy of GSK’294 in severe eosinophilic asthma (SEA). A company statement says GSK’294 is an investigational medicine with the potential to become the
Devices
FDA has granted BioFire Diagnostics a De Novo marketing authorization for the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs obtained from individuals suspected of Covid-19 and other respiratory
Drugs
FDA acting commissioner Janet Woodcock and associate commissioner for regulatory affairs Janet McMeekin say the agency has used alternative oversight tools when the pandemic prevented investigators from entering facilities for inspections. Writing in an FDA Voice post, the two say the agency prioritized “mission-critical” inspections on a case-by-
Drugs
AbbVie says that the utility and scope of an FDA draft guidance on developing drugs to treat dry eye could be increased by including recommendations for the use of biomarkers as an efficacy endpoint for the signs of dry eye and the use of patient-reported outcomes/instruments in dry
Drugs
Lilly says its mirikizumab met the primary and all key secondary endpoints in the LUCENT-1 Phase 3 induction study evaluating the drug’s safety and efficacy in treating patients with moderate to severe ulcerative colitis. The company says LUCENT-2, a multicenter maintenance study in patients who completed the
FDA Policy/General
Federal Register notice: FDA is reopening the comment period for a 6/1/2020 notice entitled “Listing of Patent Information in the Orange Book; Establishment of a Public Docket; Request for Comments.” Electronic or written comments should be submitted by 4/15. To view the notice, click here.