Drugs
The Utah federal court has issued a temporary restraining order to stop two companies and their owner from selling silver products for the treatment and prevention of Covid-19. A Justice Department statement says the injunction was entered against Gordon Pedersen, Cedar Hills, UT, and his companies My Doctor Suggests
Drugs
The CBER Office of Compliance and Biologics Quality says its review of the Web site maintained by Infuze MD, Milpitas, CA, determined that the firm markets “IV Stem Cell Therapy,” administered intravenously to treat several diseases or conditions. A 4/27 Notice of Violation said CBER also determined that at
Drugs
FDA has approved a new Boxed Warning for labeling for Merck’s Singulair (montelukast) and generics to increase awareness of potential mental health side effects. An agency notice says the Boxed Warning will be added to both the prescribing information and a medication guide. The notice says FDA took the
Devices
Six Skadden Arps attorneys say that from 2014 through 2019 the Justice Department brought enforcement actions against 67 medical technology companies. The actions led to criminal and civil fines and penalties totaling more than $1.9 billion. “As federal spending on health care increases markedly in response to the Covid-
Devices
FDA has granted an emergency use authorization for a new high-pressure ventilator developed by NASA engineers for treating coronavirus patients. The device, called VITAL (Ventilator Intervention Technology Accessible Locally) was developed by engineers at NASA’s Jet Propulsion Laboratory (JPL) in California. The Office of Technology Transfer and Corporate
Drugs
Vascular Solutions has recalled (Class 1) the Langston Dual Lumen Catheter due to the potential for the inner catheter to separate during use. If the separation occurs, it could cause serious health conditions including additional surgical procedures to remove the separated section, damage to the blood vessel or death, a
Devices
CME America has decided to remove from the market all recalled (Class 1) BodyGuard Infusion Pump Systems because they may under or over infuse medications. The reason for the infusion errors is not known, a recall notice says. Using an affected infusion pump may cause serious adverse health consequences including
Drugs
FDA says GSK Consumer is recalling five lots of its Benefiber Healthy Shape Prebiotic Fiber Supplement powder and Benefiber Prebiotic Fiber Supplement powder due to the potential for green plastic pieces or shavings from bottle caps to be in the product. A recall notice says there is a potential risk
FDA Policy/General
Federal Register notice: FDA has announced a new date, 6/30, for an earlier postponed public meeting entitled “Modernizing FDA’s Data Strategy.” The agency has also extended the comment period for a 1/8 Federal Register notice on approaches to data quality, data stewardship, data exchange, and data analytics.
Drugs
Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) have released a concept paper for their bipartisan “Cures 2.0.” The two say the paper looks at high levels of focus for Cures 2.0, which will look to safely and efficiently modernize the delivery of healthcare in the
FDA Policy/General
Federal Register notice: FDA has announced that a 5/4 public workshop entitled “FY2020 Generic Drug Regulatory Science Initiatives” is being modified to take place remotely. Participants are also asked to submit either electronic or written comments on the workshop by 6/4. To view the notice, click here.
Drugs
The Association of American Physicians and Surgeons (AAPS) has written Arizona governor Doug Ducey asking that he rescind a month-old moratorium forbidding prophylactic use of chloroquine (CQ) or hydroxychloroquine (HQ) during the Covid-19 pandemic unless peer-reviewed evidence becomes available. In the 4/27 letter, the association links
Devices
FDA has granted marketing authorization for the Medtronic Carpediem system of continuous renal replacement therapy (CRRT) for use in pediatric patients with certain kidney conditions. An agency statement says that CRRT involves using a dialysis machine and a special filter to continuously clean a patient’s blood for an extended
Drugs
FDA says QuVa Pharma is recalling all lots of RECK (ropivacaine, epinephrine, clonidine, ketorolac) 50 ml in sodium chloride-60 ml BD syringe that were prepared using sterile ketorolac being recalled by Fresenius Kabi. An FDA recall notice says Fresenius recalled multiple lots of ketorolac 4/20 due to the
Drugs
New clinical data show that Gilead’s investigational antiviral remdesivir may block Covid-19 and lead to quicker recoveries for those stricken with the virus, NIH National Institute of Allergy and Infectious Diseases (NIAID) director Anthony Fauci said in remarks made at the White House 4/29. A preliminary data
Biologics
With the abrupt ouster of Rick Bright as director of the HHS Biomedical Advanced Research and Development Authority (BARDA), CBER director Peter Marks has been positioned as the administration’s unofficial vaccine “czar,” providing input to BARDA and other federal organizations working on a Covid-19 vaccine. Politico reports that
Drugs
A Government Accountability Office (GAO) report says FDA and other federal agencies should be doing more to better determine the magnitude and reduce the impact of antibiotic resistance. GAO says it was asked to review federal efforts to address antibiotic resistance. Its report looked at federal efforts and challenges related
Drugs
FDA has rescheduled for 6/30 a public meeting to discuss possible agency-level approaches to modernizing FDA’s data strategy, including approaches to data quality, data stewardship, data exchange, and data analytics. A meeting notice says the agency also is soliciting public comments on the topic. A 9/2019
Devices
FDA has cleared a Personal Genome Diagnostics 510(k) for PGDx eliotissue complete, a diagnostic kit that can be used by molecular laboratories to perform genomic profiling of cancer. The device detects single nucleotide variants and small insertions and deletions (indels) in more than 500 genes, select amplifications and translocations,
Devices
FDA has cleared a Life Spine 510(k) to market implant and instrument additions to its ARx Spinal System. The additions are intended to provide surgeons with tools to accommodate a larger range of complex and deformity spinal procedures,” the company says. The device acts as a spacer to maintain
Drugs
Sanofi and Regeneron Pharmaceuticals have stopped a Libtayo (cemiplimab) Phase 3 trial early after the primary endpoint of overall survival (OS) was met. The trial was comparing the PD-1 inhibitor to platinum doublet chemotherapy in patients with first-line locally advanced or metastatic non-small cell lung cancer that
Biologics
The CBER Office of Compliance and Biologics Quality says Regenerative Solutions of New Jersey, Edison, NJ, is marketing exosome products from Kimera Labs for numerous diseases or conditions, including treating Covid-19. A 4/10 untitled letter says the products are administered by various routes, including intravenously. The letter quotes