Drugs
House Committee on Oversight and Accountability chairman James Comer (R-KY) and Subcommittee on Health Care and Financial Services chairwoman Lisa McClain (R-MI) are calling on FDA to provide extensive information on its response to a growing number of what they say are critical drug shortages delaying and prohibiting
Drugs
FDA has accepted for review a Supernus Pharmaceuticals NDA resubmission for its apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s disease. The agency has set a user fee review action target date of 4/5/2024. FDA 10/2022 issued a
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Enforcement Policy for Clinical Electronic Thermometers.” The document describes enforcement policies on certain legal requirements for clinical electronic thermometers, including those with and without telethermography or continuous temperature measurement functions. To view the notice, click here.
Devices
FDA has cleared an Empatica 510(k) for two new digital biomarkers for its Empatica Health Monitoring Platform — pulse and respiratory rate. “With the addition of pulse and respiratory rate, the Empatica Health Monitoring Platform now includes six FDA-cleared digital biomarkers for use in clinical trials,” Empatica says. The
Drugs
The Harvard Drug Group (doing business as Major Pharmaceutical and Rugby Laboratories) has recalled all lots of polyvinyl alcohol, 1.4% lubricating eye drops and lubricating tears eye drops (dextran/hypromellose, 0.1%/0.3%). The products are supplied by Velocity Pharma and Harvard Drug Group received information from FDA
Biologics
A BMJ investigation by senior editor Peter Doshi explores the “revolving door” between FDA and its regulated industries as shown in the case of two senior CBER Office of Vaccine Research and Review officials who now work for Moderna. One of the officials, Doran Fink, had an active public government
Drugs
Eli Lilly says that an FDA review decision for its experimental Alzheimer’s drug donanemab has been pushed back to the first quarter of 2024. It had previously expected an agency decision by 12/31. In an 11/2 earnings call, Lilly said FDA asked for more time to evaluate
Devices
FDA has issued a final guidance entitled “Enforcement Policy for Clinical Electronic Thermometers.” The agency describes clinical electronic thermometers as devices used to measure and monitor the body temperature of patients as an important screening and diagnostic tool to assist in identifying those who have a range of conditions or
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions.” The document outlines FDA’s policies and regulatory review expectations after the Covid–19 public health emergency for certain limited modifications of a
Devices
The attorneys general in 25 states are calling on FDA to act urgently to address the inaccuracy of pulse oximeters when used on people with darker-toned skin. In an 11/1 letter to FDA commissioner Robert Califf, the officials note that one year ago the agency held a public
Devices
CDRH is soliciting public comment on a series of topics and questions about how digital health technologies (DHTs), including those enabled by artificial intelligence/machine learning, may help with the early detection of risk factors for Type 2 diabetes, prediabetes, and Type 2 undiagnosed diabetes. An online post says the
Devices
FDA has approved an Abbott molecular human papillomavirus (HPV) test for HPV screening and assessment of high-risk (HR) cancer-causing types of HPV. A company statement says the Alinity m HR HPV assay is also approved for use in combination with a Pap test for patients and doctors who
Drugs
Three CDER Office of Clinical Pharmacology researchers say their comprehensive retrospective analysis of the data supporting manufacturing changes for licensed monoclonal antibodies and Fc-fusion proteins “provides an understanding of the regulatory experience and industry practice, which could facilitate developing appropriate comparability approaches to support manufacturing changes in the future.
Drugs
FDA has granted I-Mab a breakthrough therapy designation for felzartamab, an investigational CD38 antibody for treating primary membranous nephropathy (PMN). The designation was based on clinical data from the M-PLACE Phase 1b/2a proof-of-concept, open-label study, according to the company. “We believe that the cellular
FDA Policy/General
Republican members of the House Energy and Commerce Committee say they are “deeply concerned that FDA is not meeting important federal safety requirements to protect employees and the public while also failing to prioritize scientific data quality delivered from FDA laboratories.” In an 11/1 letter to FDA commissioner Robert
Drugs
FDA has placed a partial clinical hold on a Nurix Therapeutics clinical study (NX-2127-001) that is evaluating NX-2127 in various B-cell malignancies. The company says the hold is based on its communication to the agency about its intention to transition to an improved manufacturing process. Nurix
FDA Policy/General
Federal Register notice: FDA is announcing the renewal of its Patient Engagement Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 10/6/2025. To view the notice, click here.
Devices
FDA has issued an immediately effective guidance, Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions, saying the agency will not object to certain limited modifications within the scope of the guidance being implemented with a retrospective update in the next periodic report.
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) for use with gemcitabine and cisplatin for locally advanced unresectable or metastatic biliary tract cancer (BTC). Approval was based on data from KEYNOTE-966 (NCT04003636), a multicenter, randomized, double-blind, placebo-controlled trial that evaluated 1,069 patients with locally advanced unresectable or
Drugs
Former FDAer Steve Lynn says an analysis of form FDA-483 inspection reports since 2000 shows the leading observations have remained essentially the same. Writing in a Regulatory Compliance Associates online post, Lynn asks how the industry, both the regulators and the regulated, can solve the systemic repeat observations. Using
FDA Policy/General
Federal Register notice: FDA is seeking interested industry organizations to participate in selecting nonvoting industry representatives to serve on certain CDRH panels of the Medical Devices Advisory Committee. The agency is also requesting nominations for nonvoting industry representatives to serve on the panels, and it notes that a nominee may
FDA Policy/General
Federal Register notice: FDA is issuing an order granting special termination of the debarment of David Winne, effective 8/28/2024. In August, Winne was permanently debarred from providing services related to an approved or pending drug product application. The debarment was based on Winne’s felony convictions as a