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
Devices
FDA has issued an immediately-in-effect guidance to “provide a policy to help expand the availability of digital health therapeutic devices for psychiatric disorders to facilities consumer and patient use while reducing user and healthcare provider contact and potential exposure to Covid-19 during this pandemic.” The document says
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV.” The International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products document is intended as an annex to an associated
Drugs
FDA and the Federal Trade Commission say that their review of the Web site and Facebook page maintained by Gaia Arise Farms Apothecary, Waynesville, NC, found offers to sell a product known as True Viral Defense or Viral Defense Tincture intended to mitigate, prevent, treat, diagnose, or cure Covid-19.
Drugs
FDA has sent Herbs of Kedem a Warning Letter after reviewing the company’s Web site (www.kedemnatural.com) and determining that it is offering for sale unapproved new drugs for treating Covid-19 patients. The company is promoting its herbal products as being safe and effective for treating Covid-
Drugs
FDA has extended until 6/5 the deadline to apply for a funding opportunity to examine the use of real-world data (RWD) to generate real-world evidence (RWE) in regulatory decision-making. FDA intends to encourage innovative approaches to further explore RWD use while making sure that scientific evidence
Devices
FDA commissioner Steve Hahn says that ramping up of caronavirus testing, both diagnostic and new antibody tests, will be necessary to gradually allow people who are isolating at home to return to work. Speaking 4/12 on ABC’s “This Week With George Stephanopoulos,” Hahn contradicted president Trump’s statement
FDA Policy/General
FDA says it is permitting the use of home-use blood glucose meters by patients with diabetes who are hospitalized due to COVID-19 to check their own blood glucose levels and provide the readings to the health care personnel caring for them. Such use can be an option to
FDA Policy/General
Federal Register notice: FDA has made available two final guidances entitled “Guidance on Chloroquine Phosphate” and “Guidance on Hydroxychloroquine Sulfate.” The documents provide product-specific recommendations on, among other things, the design of bioequivalence studies to support ANDAs. To view the notice, click here.
Drugs
A just-published study report in the New England Journal of Medicine on the compassionate use of Gilead’s investigational remdesivir in Covid-19 patients shows improvement in oxygen-support status in 68% of patients, and overall mortality was 13% over a median follow-up of 18 days. The small
Devices
FDA has released a final guidance entitled “Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products.” The document recommends certain factors companion diagnostic developers should consider when determining whether their test could be developed, or if labeling for approved companion diagnostics could be
Devices
FDA has granted BD (Becton, Dickinson) an emergency use authorization for a molecular diagnostic test for Covid-19 that can return results in two to three hours. The test is based on the CDC assay design and is run on the BD Max System, which performs other tests from collaborations
FDA Policy/General
Notice Corrected on ANDA Approval Withdrawals Federal Register notice: FDA corrects a 1/8 Federal Register notice that announced the withdrawal 23 ANDAs. 04/07/2020 User Fee Report on Drug/Biosimilar Review Resources Federal Register notice: FDA posts a user fee-related report providing options and recommendations for a
FDA Policy/General
Menarini-Silicon Biosystems has completed its agreement to purchase all the assets and relevant business related to the CellSearch Circulating Tumor Cell System from Janssen Diagnostics. The FDA-cleared blood test is intended for detecting and enumerating circulating tumor cells (CTCs) to help manage patients with metastatic breast, prostate, and
Devices
FDA has issued an emergency use authorization to Terumo BCT and Marker Therapeutics for their Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices that serve as a blood purification system to treat patients with confirmed Covid-19 admitted to the intensive care unit with confirmed or imminent respiratory
Drugs
FDA has sent a Warning Letter to Earthly Wellness over unapproved and misbranded products related to Covid-19. The letter says that FDA and FTC reviewed the company’s Web and social media sites promoting herbal tinctures and herbal remedy products for treating Covid-19 despite the products not being
Drugs
Novartis says it has confirmed a safety signal with Beovu (brolucizumab) involving “retinal vasculitis and/or retinal vascular occlusion with or without presence of intraocular inflammation that may result in severe vision loss.” Beovu is a human vascular endothelial growth factor inhibitor indicated for treating neovascular (wet) age-related macular
Drugs
FDA has issued a guidance entitled “Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders Not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency.” The document discusses how pharmacies may be able to preserve personal protective equipment used in their compounding operations if
Devices
FDA has issued a second emergency use authorization (EUA) for decontaminating compatible N95 or N95-equivalent respirators for reuse by health care workers in hospital settings. The EUA was issued to Steris Corp. for the Steris V-Pro 1 Plus, maX and maX2 Low Temperature Sterilization Systems with the Steris
Drugs
FDA has approved an AstraZeneca NDA for Koselugo (selumetinib) for treating of pediatric patients with neurofibromatosis type 1 (NF1), a nervous system genetic disorder that causes tumors to grow on nerves. FDA says that Koselugo is approved specifically for patients who have symptomatic, inoperable plexiform neurofibromas (PN), which are tumors
Devices
FDA has granted Vapotherm a breakthrough device designation for its Oxygen Assist Module for use in the company’s Precision Flow system, a mask-free alternative to nasal continuous positive airway pressure as well as noninvasive positive pressure ventilation. The module assists staff in maintaining a targeted SpO (amount of
Drugs
FDA is directing industry to a new guidance from HHS’ Office for Human Research Protections (OHRP) entitled “OHRP Guidance on Covid-19.” The guidance responds to questions the office has received from the research community about how human subjects protection regulations (45 CFR part 46) apply to actions taken by