Devices
FDA has posted a new guidance entitled “Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency.” The document is intended to provide a policy to help expand the availability of devices for remote reviewing and reporting of scanned digital images of pathology
Drugs
FDA has issued a MedWatch safety alert on off-label hydroxychloroquine or chloroquine use for Covid-19 outside of a hospital setting or a clinical trial due to risk of heart rhythm problems. President Trump and his allies have been touting the drug for weeks until recently when new data
Biologics
Some 35 members of the House of Representatives led by Reps. William Foster (D-IL) and Donna Shalala (D-FL) have written to FDA commissioner Stephen Hahn and HHS secretary Alex Azar asking them to consider conditions under which a Covid-19 vaccine might be approved and deployed more rapidly
Devices
FDA 4/23 issued an immediately-in-effect guidance to help increase availability and capability of imaging products needed for diagnosis and treatment monitoring of lung disease in patients with Covid-19. The agency said affected imaging products include medical x-ray, ultrasound and magnetic resonance imaging systems, and image
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision for “Imports and Electronic Import Entries”(OMB Control Number 0910-0046). The revision pertains to a weekly entry filing program that is available for some FDA-regulated products, and it allows entry filers to file a single entry
Drugs
FDA has issued Warning Letters to two companies for illegally selling unapproved products containing cannabidiol (CBD) that violate the Federal Food, Drug and Cosmetic Act. BIOTA Biosciences received one letter for marketing and distributing injectable CBD products for serious diseases and as an alternative to opioids. Homero Corp DBA Natures
Drugs
Rep. Rosa DeLauro (D-CT) has written to secretary of veterans affairs Robert Wilkie asking that the agency stop using hydroxychloroquine to treat Covid-19 patients pending further evaluation. In a 4/23 letter, DeLauro said the National Institute of Allergies and Infectious Diseases released 4/22 guidelines establishing that
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Drug Supply Chain Security Act Implementation” (OMB Control Number 0910-0806). The revision is mandated under the Drug Supply Chain Security Act (DSCSA) and pertains to certain provisions of the DSCSA to also include information collection activity
FDA Policy/General
The Maryland federal court has granted an FDA request to extend to 9/9 the 5/12 deadline for manufacturers of e-cigarettes, cigars, and other deemed new tobacco products that were on the market as of 8/8/16 to submit applications for premarket review. An agency statement said
Devices
FDA has cleared a Cagent Vascular 510(k) for its Serranator PTA Serration Balloon Catheter for treating below-the-knee (BTK) lesions. The device uses the company’s serration technology in a semi-compliant balloon for treating peripheral artery disease, the company says. It is designed to create multiple longitudinal
Drugs
FDA has published an immediately-in-effect guidance, Temporary Policy on Repackaging or Combining Propofol Drug Products During the Covid-19 Public Health Emergency, to describe the enforcement discretion it will exercise on the repackaging or combining of propofol general anesthesia drug products by a licensed pharmacist in a state-
Drugs
ProPharma Group says pharmaceutical companies should always be ready for planned and unplanned internal and external inspections. In an online post, “Although there are various types of audits and inspections,” the post says, “and in the current landscape there has been a shift to virtual audits, there is a trend
Devices
Stakeholders say they support an FDA proposal to reclassify human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and human immunodeficiency virus nucleic acid diagnostic and supplemental tests from Class 3 to Class 2 with special controls. The Association of Public Health Laboratories says the change will “achieve urgently needed
Devices
FDA has granted Baxter International an emergency use authorization for the Oxiris filter set to treat patients who have confirmed Covid-19 and have been admitted to the intensive care unit with confirmed or imminent respiratory failure in need of blood purification therapy to reduce pro-inflammatory cytokine levels, including
Drugs
CNS Pharmaceuticals has requested an FDA orphan drug designation for its lead product berubicin for treating glioblastoma, one of the most aggressive forms of cancer. The request is based on Phase 1 trial data showing a significant improvement in progression free survival, the company says. A Phase 2 trial evaluating
Drugs
During the Covid-19 pandemic, FDA has stepped up seizures of prescription drugs mailed to American customers from pharmacies in Canada and other countries, according to a Kaiser Health News article reprinted online by Salon. Often, it says, the recipients are individuals trying to avoid trips to a pharmacy because
Devices
FDA says that Trividia Health is recalling one isolated True Matrix Air blood glucose meter distributed in the U.S. to AssuraMed. An agency announcement says the company determined that the meter was packaged into a True Metrix blood glucose meter kit and has an incorrect factory-set unit of
FDA Policy/General
Federal Register notice: FDA has extended the comment period on a 1/30-published draft guidance entitled “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations.” Electronic or written comments can now be submitted by 7/28. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Nonbinding Feedback After Certain FDA Inspections of Device Establishments.” The document identifies a standardized method for communicating and submitting requests for nonbinding feedback and describes how FDA evaluates and responds to such requests. To view the notice, click here.
FDA Policy/General
The FDA Office of Minority Health and Health Equity (OMHHE) is marking its 10th anniversary during National Minority Health Month observances in April. In an FDA Voices online post, agency associate commissioner for minority health Richardae Araojo says that in the last 10 years FDA has increasingly focused on and
Drugs
FDA has accepted for review a Mallinckrodt NDA for terlipressin, indicated for treating hepatorenal syndrome type 1 (HRS-1). Terlipressin is a potent vasopressin analog selective for V1 receptors, Mallinckrodt says. The agency set a 9/12 user fee review action target date, and the company expects an FDA advisory
Drugs
FDA has approved an Immunomedics BLA for Trodelvy (sacituzumab govitecan-hziy) for treating adult patients with triple-negative metastatic breast cancer. The agency says that patients must have received at least two prior therapies before taking Trodelvy. The accelerated approval was granted one month ahead of its user fee review