FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Ficosota, Shumen, Bulgaria (2/28): FDA inspected the company 9/2019 and cited significant GMP violations for finished pharmaceuticals. For example, Ficosota failed to have an appropriate laboratory determination
Devices
FDA has released a guidance on “Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency.” The document says that during the coronavirus outbreak, the agency does not intend to object to “limited modifications to the indications or functionality of FDA-
FDA Policy/General
Federal Register notice: FDA is amending its animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications made during 10/2019, 11/2019 and 12/2019. FDA is also making available summaries of the basis of approval and of environmental review
Drugs
With the president’s signing of the $2 trillion stimulus bill 2/27, FDA says it is pleased with an additional $80 million to fund its Covid-19 response efforts. The funding will go to developing medical countermeasures and vaccines, promoting advanced manufacturing for medical products and monitoring the medical
Drugs
FDA has released a guidance on “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act.” During the Covid-19 pandemic, FDA has been closely monitoring the medical product supply chain to see how it may be impacted by the outbreak.
Drugs
FDA has issued an updated guidance entitled “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic.” The document has an appendix on common questions and answers. It was issued earlier in the month because the agency recognizes that the Covid-19 pandemic may impact medical product clinical trials.
Devices
FDA has approved a Zoll Medical PMA for the TherOx System, which provides supersaturated oxygen (SSO2) therapy to reduce heart muscle damage in “widowmaker” heart attack patients. Zoll says the device delivers hyperbaric levels of oxygen directly to the damaged heart muscle immediately after successful revascularization through angioplasty and stenting
Devices
Battelle has announced an emergency use authorization for its Critical Care Decontamination System for decontaminating respirator masks. It says each device system is capable of decontaminating up to 80,000 respirator masks per day using concentrated, vapor phase hydrogen peroxide. The masks are exposed to the validated concentration level for
Drugs
FDA has approved an Eli Lilly supplemental BLA for Taltz (ixekizumab) injection, 80 mg/mL, for treating pediatric patients (ages six to under 18) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The pediatric use’s approval was based on safety, tolerability and efficacy
Drugs
[Report by James G. Dickinson and David McFarland] In what some close observers saw as a hidden political directive from President Trump, FDA 3/30 issued an emergency use authorization (EUA) to permit the distribution and use of 30 million doses of hydroxychloroquine sulfate donated by Sandoz and one million
FDA Policy/General
DEVICES FDA has approved a Boston Scientific PMA for the Innova Vascular Self-Expanding Stent System, a treatment for patients with narrowing or blockages in the superficial femoral artery or proximal popliteal artery. The device comprises a Nitinol self-expanding bare metal stent with an advanced delivery system, and is
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension related to its guidance entitled “Combination Products: How to Write a Pre-Request For Designation (RFD).” The document clarifies the type of information the agency’s Office of Combination Products (OCP) recommends that a sponsor include in a
Drugs
Dr. Reddy’s Laboratories has recalled four lots of phytonadione injectable emulsion, 10 mg/mL single-dose ampules due to the potential for ampules to break and shatter upon opening. According to a recall notice, the company has received reports of cuts and lacerations from breakages. “There may be a
Drugs
FDA has released a guidance entitled “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act.” The document is intend to help FDA with monitoring the medical product supply chain, which may be impacted by the Covid-19 outbreak and potentially
Devices
FDA has released a guidance entitled “Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A.” The document provides the Center’s interpretation of key provisions in the regulation that pertain to requests for appeals of significant decisions on PMAs, 510(k)s, IDEs, and clinical
Drugs
FDA 3/26 sent a Warning Letter to Carahealth (Galway, Ireland) objecting to herbal products being offered online for treating Covid-19 patients. For example, one claim the company was making said: “Coronavirus (COVID-19, SARS-CoV-2) pandemic has no medical treatment. Natural antiviral herbs boost immunity & decrease
FDA Policy/General
Federal Register notice: FDA has canceled the 5/15 Allergenic Products Advisory Committee meeting to allow more time for the agency to review outstanding issues related to the safety and efficacy of DBV Technologiesֺ’ Peanut (Arachis hypogaea) Allergen Extract. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has modified the list of standards it recognizes for use in medical device premarket reviews (“Modifications to the List of Recognized Standards, Recognition List Number: 053”). The listing is intended to assist manufacturers who elect to declare conformity with consensus standards to meet certain device requirements.
Devices
FDA has posted “Frequently Asked Questions on 3D Printing of Medical Devices, Accessories, Components, and Parts During the Covid-19 Pandemic.” The document provides the agency’s current thinking for those intending to use 3D printing to assist in meeting demand for certain products during the Covid-19 pandemic. FDA
Drugs
Despite the repeated recommendations from president Trump to use chloroquine to treat coronavirus patients, principal deputy commissioner Amy Abernethy this week reiterated that a randomized controlled trial is the “most appropriate way” to determine whether the malaria drug is safe and effective for such use. Speaking remotely at the Wall
FDA Policy/General
FDA has just released the FDA-483 issued following a 10/2-12/18/17 inspection at Innovative Intrathecal Solutions, doing business as Innovative Compounding Pharmacy, a Marietta, CA, producer of human and veterinary drug products. Specific observations on the form were: * procedures designed to prevent microbiological contamination of drug
Devices
FDA has issued an emergency use authorization for ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors, and ventilator accessories to provide more needed devices for use in healthcare settings. The authorization covers devices that are not