FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Submission of Information on Pediatric Uses of Medical Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure Under Section 515A
Drugs
Bayer’s donation of three million Resochin (chloroquine phosphate) tablets to the U.S. national stockpile for use in treating Covid-19 patients is raising red flags, according to a Reuters article. The news service says three U.S. government sources familiar with the donation told it there is reason
Drugs
FDA has accepted for priority review a Regeneron Pharmaceuticals BLA for REGN-EB3, an investigational triple antibody cocktail treatment for Ebola virus infection. The agency has set a user fee review action target date of 10/25. The submission is supported by data from the randomized, controlled PALM clinical trial
Devices
FDA has granted an emergency use authorization for Synapse Biomedical and its TransAeris Diaphragmatic Pacing Stimulator System that is intended to help wean patients off ventilators, including COVID-19 patients. Diaphragm pacing can free up ventilators as patients are moved off ventilators and placed on the pacing system, the company
Drugs
The International Council for Harmonization (ICH) says its S11 guideline on nonclinical safety testing supporting the development of pediatric medicine reached Step 4 of the ICH process this month. ICH says the guideline provides direction on the nonclinical safety studies important to support a pediatric development program. It reportedly recommends
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a proposed information collection entitled “FDA Advisory Committee Membership Nominations” (OMB Control Number 0910-0833). To identify and select qualified individuals to serve on its advisory committees, FDA has established an online portal — the FDA Advisory Committee Membership Application — to accept nominations
Drugs
FDA says that a Web site operating at unitedpharmacies.md is offering drug products for sale in the U.S. intended to mitigate, prevent, treat, diagnose, or cure Covid-19 in people. A just-released 3/30 Warning Letter says the firm’s products are considered to be unapproved new
Drugs
FDA has approved a UroGen Pharma NDA for Jelmyto (mitomycin gel), indicated for treating low-grade upper tract urothelial cancer (UTUC). FDA describes Jelmyto as an alkylating drug that “inhibits the transcription of DNA into RNA, stopping protein synthesis and taking away the cancer cell’s ability to multiply.” Approval
Devices
FDA has granted emergency use authorizations to two Covid-19 antibody tests — Chembio Diagnostic System’s DPP COVID-19 IgM/IgG System and Ortho Clinical Diagnostics’ Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack. The two serology tests will aid in determining whether somebody has already been exposed
Devices
Viveve Medical says it has resubmitted to FDA its IDE for approval to begin a stress urinary incontinence (SUI) multi-center trial now known as PURSUIT (Prospective U.S. Radiofrequency SUI Trial). The company says the trial is designed to evaluate the safety and efficacy of Viveve's CMRF
Drugs
The United States Pharmacopeia (USP) says it supports efforts to foster access to biosimilars and to pursue initiatives that facilitate increased competition for biological products. Commenting on an FDA/Federal Trade Commission 3/9 workshop on a competitive marketplace for biosimilars, USP says its public quality standards “serve an important
FDA Policy/General
Federal Register notice: FDA has withdrawn a 3/6 Federal Register notice on a proposed information collection entitled “Food and Drug Administration Safety Communication Readership Survey.” The agency is withdrawing the collection request because it determined that it is more appropriate to include the estimated burden in the agency’s
Drugs
FDA has granted RemeGen a fast track designation for RC18, a novel recombinant TACI-Fc (transmembrane activator and calcium modulator and cyclophilin ligand interactor) fusion protein for treating systemic lupus erythematosus. The chronic autoimmune disease attacks healthy tissue and affects upwards of 1.5 million people in the U.S.
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. American Fertility Medical Center, Irvine, CA (4/2): FDA inspected the firm 1/14-22 and documented significant deviations from the regulations for human cells, tissues, and cellular and
FDA Policy/General
Federal Register notice: FDA has extended the comment period until 6/19 for a request for information entitled “Request for Information on Vaping Products Associated with Lung Injuries” that appeared in the 2/18 Federal Register. To view the notice, click here.
Drugs
The New Civil Liberties Alliance (NCLA) says it is concerned that an FDA decision that will prevent the dissemination of information related to the genetic variants on drug response (pharmacogenomics or PGx) will adversely affect public health. The NCLA concern is expressed in its 4/14 comment supporting a 1/
Drugs
An 8/13-8/17/19 FDA inspection at a subsidiary of Option Care Health, HomeChoice Partners, doing business as Bioscrip Infusion Services, Augusta, GA, found “serious deficiencies in this facility’s practices for producing sterile drug products, which put patients at risk.” A 4/9 Warning Letter says specific
Drugs
Two stakeholders are suggesting changes in an FDA draft guidance on bridging for drug-device and biologic-device combinations. AdvaMed’s comment letter commends the agency for implementing the guidance and offers “minor revisions to improve the clarity and impact” of the document. The Biotechnology Innovation Organization says the draft
Devices
FDA has approved Intact Vascular’s Tack Endovascular System (4F), described by the company as a minimal metal implant for precision dissection repair in the mid/distal popliteal, tibial and peroneal arteries. Approval was based on data from the company’s Tack Optimized Balloon Angioplasty II Below the Knee clinical
Drugs
India’s Economic Times reports that FDA has cleared within 10 days four drug manufacturing facilities operated by the country’s leading drug companies at a time when supply chain disruptions caused by the coronavirus pandemic are creating drug shortages worldwide. Cleared were Lupin’s Nagpur manufacturing facility, Dr. Reddy’
Drugs
FDA has accepted for priority review a Fennec Pharmaceuticals NDA for Pedmark (sodium thiosulfate), indicated for preventing ototoxicity (hearing loss) induced by cisplatin chemotherapy in patients one month to 18 years of age with localized, non-metastatic, solid tumors. The agency set a user fee review action target date of
Drugs
Kadmon Holdings says it has received FDA meeting minutes on a planned NDA submission for KD025 for treating patients with chronic graft-versus-host disease (cGVHD). Based on the FDA feedback, the company believes its proposed data package will be sufficient to support the NDA, which will include data from