Drugs
FDA has approved Regeneron Pharmaceuticals’ Dupixent (dupilumab) for treating adult patients with prurigo nodularis, a chronic, debilitating skin disease with underlying Type 2 inflammation. Approval was based on data from two Phase 3 trials, PRIME and PRIME2, that assessed the proportion of subjects with clinically meaningful reduction in itch, clearing
Drugs
Pharmaceutical Research and Manufacturers of America suggests several ways FDA could improve its draft guidance on selecting, developing, or modifying fit-for-purpose clinical outcome assessments. The association’s comment letter calls for changes to expand the guidance’s scope and provide consistency in terminology across the agency’s patient-
Drugs
The Senate unanimously passed 9/29 the bipartisan FDA Modernization Act 2.0 (S. 5002), introduced by Sens. Rand Paul (R-KY) and Cory Booker (D-NJ). A statement (contains a link to the bill) issued by Paul says the legislation “ends an outdated FDA mandate that experimental drugs must
Devices
FDA has cleared a Medtronic 510(k) for its Nexpowder endoscopic hemostasis system. The device uses a noncontact, nonthermal hemostatic powder, which is sprayed through a catheter that has a proprietary powder coating to minimize clogging and provide improved visibility and control for treating upper gastrointestinal nonvariceal bleeding, according to
Drugs
FDA has approved Amylyx’s amyotrophic lateral sclerosis (ALS; also known as Lou Gehrig's disease) drug AMX0035 (sodium phenylbutyrate and taurursodiol). The agency green light comes after an unprecedented second advisory committee vote within six months reversed its earlier negative recommendation to back the drug in a 7
Drugs
FDA has released the form FDA-483 issued following a 5/10-5/20 inspection at the Delta Pharma outsourcing facility in Ripley, MS. The inspection observations were: * clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform; * aseptic processing areas are
Biologics
FDA has approved a Celltrion BLA for Vegzelma (bevacizumab-adcd), a biosimilar to Genentech’s Avastin (bevacizumab), for treating six cancer types: metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial
Drugs
Eisai and Biogen say the Phase 3 confirmatory Clarity AD trial of their lecanemab (BAN2401), an investigational anti-amyloid beta protofibril antibody to treat mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease with confirmed presence of amyloid pathology, successfully met all primary and secondary endpoints.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Clinical Decision Support Software.” The document describes FDA’s oversight of such software intended for use by health care professionals. It also clarifies the types of software functions that do not meet the definition of a device as amended
Drugs
Researchers at the University of California San Francisco say their review of 15 oncologic drug surrogate outcome analyses published by FDA from 2005 to 2002 found that the vast majority of the analyses did not find strong correlations between a surrogate outcome and overall survival. In fact, they say, of
Devices
FDA has published a guidance, Policy for Device Software Functions and Mobile Medical Applications, to inform manufacturers, distributors, and other entities about how the agency intends to apply its regulatory authorities to select software functions intended for use on mobile platforms or general-purpose computing platforms. “Given the rapid expansion
Devices
FDA says it will collaborate with the Veterans Health Administration on efforts to help accelerate American medical device innovation to further improve and benefit public health. An agency notice says the VA Ventures Innovation Institute in Seattle, WA, will host up to 12 FDA staff to foster robust collaboration between
Drugs
FDA has issued Avidity Biosciences a partial clinical hold on new participant enrollment in its Phase 1/2 MARINA clinical trial of AOC 100, an antibody oligonucleotide conjugate, in adults with myotonic dystrophy Type 1 (DM1). Close to 40 participants are currently enrolled in the MARINA and MARINA open label
Drugs
PTC Therapeutics says the International Council for Harmonization M12 draft guidance on drug interaction studies provides general guidelines on how to design, conduct, and interpret drug-drug interaction studies during the development of a therapeutic product. In a comment letter, PTC makes suggestions and seeks clarifications on ICH harmonized guidelines
Devices
FDA has published a guidance, Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data—Premarket Notification [510(k)] Submissions, with recommendations for 510(k) submissions for computer-assisted detection (CADe) devices applied to radiology images and radiology device data. The document says CADe devices are computerized systems
Devices
FDA has issued a revised final guidance entitled “Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions.” The document provides recommendations on clinical performance assessments of computer-assisted detection (CADe) devices applied to radiology images and
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Policy for Coronavirus Disease — 2019 Tests During the Public Health Emergency (Revised).” The document revises the enforcement policies and review priorities for certain novel coronavirus (Covid–19) tests for the duration of the public health emergency. To view the
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Providing Over-the-Counter Monograph Submissions in Electronic Format.” The document is intended to assist submitters by describing the electronic monograph submissions requirement in Section 505G(j) of the FD&C Act, and provide recommendations and other information
Devices
Attorneys Steven Gonzalez and Jeffrey Wasserstein (Hyman, Phelps & McNamara) say a recent New Jersey Supreme Court decision demonstrates that the issuance and wording of FDA safety notices can potentially affect the civil liability exposure of the customers of medical device manufacturers. Writing in their firm’s FDA Law Blog,
FDA Policy/General
Three Covington attorneys say a Department of Justice (DoJ) statement of interest in a recent Florida federal court whistleblower case “shows that the government continues to be interested in pursuing False Claims Act (FCA) cases premised on alleged violations of the Federal Food, Drug, and Cosmetic Act (FFDCA) and FDA
FDA Policy/General
Five stakeholders have raised concerns with FDA about the agency’s draft guidance, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments. Pfizer says areas for which further clarification would be beneficial are (1) defining new concepts and terms and providing additional context and examples
Drugs
FDA has published a draft guidance, Providing Over-the-Counter Monograph Submissions in Electronic Format, to assist submitters by describing the electronic over-the-counter electronic submission requirement in section 505G(j) of the Federal Food, Drug, and Cosmetic Act, which was added by the Coronavirus Aid, Relief, and Economic