Drugs
A new report from the National Academies of Sciences, Engineering, and Medicine says there is a lack of scientific evidence to support the safety or effectiveness of compounded topical pain creams. The report, “Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use,” recommends changes such as
Drugs
FDA has released for public viewing a standard memorandum of understanding (MOU) between the agency and states as part of the regulatory process addressing compounded drug distribution while preserving access. An agency notice says the compounding program is an FDA priority that develops policies that ensure appropriate access to lawfully-
Drugs
Vanda Pharmaceuticals says it has reached agreement with FDA to resubmit an NDA and supplemental NDA for Hetlioz (tasimelteon) for treating Smith-Magenis Syndrome (SMS). In March, Vanda received a refusal to file letter, asking that the company separate its NDA into two submissions — a supplemental NDA for the solid
Devices
FDA has cleared a Royal Philips 510(k) for ultrasound options for managing Covid-19-related lung and cardiac complications. “Handheld and portable ultrasound solutions in particular have become valuable tools for clinicians treating Covid-19 patients due to their imaging capabilities, portability and ease of disinfection,” the company says.
Drugs
FDA has added content to the question-and-answer appendix in its guidance on conducting medical product clinical trials during the Covid-19 public health emergency. An online notice says the guidance includes new content with considerations for using alternate laboratories or imaging centers, holding trial participant visits via video
Drugs
CDER has outlined recommendations for drug sponsors seeking product development inquiries for Covid-19 products. For example, the Center’s Office of New Drugs (OND) recommends that development for Covid-19 related drugs be supported by randomized controlled trials. OND also urges sponsors to seek initial advice under a pre-
Biologics
FDA has granted Moderna a fast track designation for its mRNA vaccine candidate (mRNA-1273) for Covid-19. “As we await the full set of clinical data from the [NIH]-led Phase 1 study, we are actively preparing for our Phase 2 and Phase 3 clinical studies to continue learning
Drugs
FDA has released the FDA-483 issued to Nephron Pharmaceuticals Corp., doing business as Nephron Sterile Compounding Center, West Columbia, SC, with nine inspection observations. The document lists these observations: * failing to write and follow test procedures relative to appropriate lab testing for sterility; * failing to follow procedures designed to
Drugs
The Court of Appeals for the DC Circuit has rejected Pharmaceutical Manufacturing Research Services’ (PMRS) request for a review of FDA decisions rejecting the company’s NDA for a prescription opioid drug and denying the company a hearing. The court concluded that the FDA decision to deny the PMRS application
Devices
FDA says an Applied Medical 10/24/19 recall of Python Embolectomy, BARD Embolecomy, and OTW Latis cleaning catheters due to the risk of separation during use is a Class 1 recall. A notice says 19,400 recalled units were manufactured between 7/23/15 and 11/8/18 and
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it “applauds FDA for seeking input on the capacity planning adjustment (CPA) methodology and the recommendations being made” in an agency report on assessing the resource needs of PDUFA and BsUFA. Completion of the assessment of CPA methodology meets an agency commitment
Drugs
An FDA 8/9-8/21/19 inspection at Images Unlimited Products, doing business as Cellect Products & Oglethorpe, as well as an agency review of labels for the firm’s products and a Web site, found serious violations of the Federal Food, Drug, and Cosmetic Act and applicable regulations.
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Fusion Health and Vitality, Alpharetta, GA (5/11): FDA reviewed the company’s Web sites and determined that it sold unapproved products intended to mitigate, prevent, treat, diagnose, or
Drugs
FDA says Web sites operated by Fusion Health and Vitality, Alpharetta, GA, sold products intended to mitigate, prevent, treat, diagnose, or cure Covid-19 in people. A 5/11 Warning Letter says the firm’s products were unapproved new drugs that were also misbranded. The letter says that as of
Drugs
FDA has updated its Purple Book: Database of FDA-Licensed Biological Products to add all FDA-licensed, biological products regulated by CDER, including biological products approved in NDAs that were deemed to be licenses on 3/23 (transition biological products). The update also includes additional downloadable report features, and historical
Drugs
FDA commissioner Stephen Hahn says that while an agency moratorium on on-site domestic and foreign facility inspections remains in place, the agency is working with the Centers on Disease Control “to develop a process that would govern how and where to return to on-site facility surveillance inspections in
FDA Policy/General
FDA commissioner Stephen Hahn, CDC director Robert Redfield and NIH National Institute of Allergy and Infectious Diseases director Anthony Fauci are under quarantine after being exposed to an unidentified White House staffer who tested positive for Covid-19. The three members of the White House Coronavirus Task Force are scheduled
Drugs
ICU Medical has recalled one lot of lactated ringer’s injection due to the presence of particulate matter identified as iron oxide. The company became aware of the issue through a single customer complaint, according to a recall notice. “Administration of a drug product that contains metal particulate matter could
Drugs
FDA has granted Daiichi Sankyo and AstraZeneca a breakthrough therapy designation for Enhertu (fam-trastuzumab deruxtecan-nxki) for treating patients with HER2 positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab. The designation was based on results from the DESTINY-
Drugs
FDA has granted Eli Lilly accelerated approval three months ahead of schedule for Retevmo (selpercatinib) for certain patients with non-small cell lung cancer or thyroid cancer. Approval was based on data from the LIBRETTO-001 clinical trial. Data showed that in NSCLC patients the overall response rate (ORR) was
Devices
FDA has issued the first emergency use authorization (EUA) for a Covid-19 antigen test. Quidel’s Sofia 2 SARS Antigen FIA diagnostic test is designed to quickly detect protein fragments found on or within the virus by testing samples collected from the nasal cavity using swabs, according to an
Devices
Singlera Genomics says it has completed a pre-submission meeting with CDRH’s Office of In Vitro Diagnostics and it was provided clear guidance on the regulatory pathway and clinical trial plan for the Singlera Genomics ColonES assay. The test is being developed as a blood-based screening assay for