Drugs
Attorney Scott Lassman has petitioned FDA to refuse to approve proposed dosing modifications sought by Par Sterile Products for its Vasostrict (vasopressin injection) based on patient genotype. The 1/29 petition says the Par request should be denied “in the absence of rigorous and convincing clinical evidence, including evidence from
Devices
University of Michigan associate professor Kevin Fu has been named to a one-year term as an expert-in-residence with CDRH as acting director of medical device cybersecurity. The university says Fu’s position is within the Center’s Office of Strategic Partnership and Technology Innovation. It says he
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. American Global Health Products, Bellevue, WA (1/22) FDA says its review of the firm’s Web site and Facebook page indicated the company takes order for several AloeCure
FDA Policy/General
The Government Accountability Office (GAO) says FDA and many other HHS agencies should be doing more as part of the government’s response to the Covid-19 pandemic. GAO also criticizes the agencies for not implementing many of its earlier recommendations. In its latest report, GAO says FDA should: * as
Devices
FDA says a Boston Scientific 12/2/20 recall of 19,919 EMBLEM S-ICD subcutaneous electrodes is Class 1. A recall notice says the electrodes are part of the Boston Scientific S-ICD implantable cardioverter defibrillator system. The company recalled the electrodes due to an increased risk of fractures
Devices
FDA has cleared an Inovytec 510(k) to market its Ventway Sparrow ventilators in the U.S. The company says the transport and emergency ventilators weigh about 2.2 pounds and allow for both invasive and noninvasive ventilation for patients weighing above 5 kg. “A built-in turbine removes dependency
Drugs
FDA has set up an interim process to communicate issues identified following a review of records or other information requested prior to or in lieu of a drug/biologic pre-approval/pre-license inspection. During the Covid-19 emergency, manufacturing records are being requested under 704(a)(4) of the
Drugs
A recent FDA pilot program has removed almost 30 illegal Web sites that were offering opioids for sale. “The pilot program has proven to be an effective tool in maximizing the impact of FDA's efforts to limit the illegal sale of unapproved opioids online and we are pleased
Drugs
Merck says Phase 3 data from the KEYNOTE-598 study evaluating its anti-PD-1 therapy Keytruda (pembrolizumab) in combination with Bristol-Myers Squibb’s Yervoy (ipilimumab) compared with Keytruda monotherapy did not show improved overall survival (OS) or progression-free survival in patients with metastatic non-small cell lung
Biologics
FDA has approved a Biogen supplemental BLA for an intramuscular (IM) injection route of administration for Plegridy (peginterferon beta-1a), indicated for treating relapsing forms of multiple sclerosis. A subcutaneous (SC) formulation of Plegridy was originally approved in 2014. Plegridy uses pegylated interferon beta-1a to extend its half-life
Drugs
Concert Pharmaceuticals is discontinuing development of schizophrenia drug CTP-692 after reporting disappointing data from a Phase 2 clinical trial evaluating it as an adjunctive treatment. According to the company, the study failed to meet the primary endpoint or other secondary endpoints. CTP-692 is described as a deuterated form
Devices
FDA has cleared a Soliton 510(k) for its Rapid Acoustic Pulse (RAP) device and technology for the short-term improvement in the appearance of cellulite. The company says that its rapid-pulsed technology safely and comfortably breaks apart the fibrous septa bands beneath the skin that cause cellulite in
Drugs
Fresenius Kabi was issued a six-item FDA Form-483 after an inspection in May 2020 documented GMP deficiencies at its Melrose Park, IL manufacturing facility. For example, Fresenius’ responsibilities and procedures applicable to the quality control unit were not in writing and fully followed, the inspection form said. The
Devices
Wahl Clipper Corp. has recalled all Deluxe Heat Therapy Massagers, Model 4212, due to overheating concerns. A recall notice says users should discontinue use immediately, adding that the connection between the massager and heat attachment can overheat causing smoke or spark, which may pose a fire hazard. To view the
FDA Policy/General
Tobacco Product Substantial Equivalence Rule Withdrawn 1/25 Federal Register notice: FDA has withdrawn a 1/21-posted final rule that provided additional information on the content and format of reports intended to demonstrate substantial equivalence of a tobacco product (SE Reports). The rule also established general procedures FDA intends
Biologics
Janssen and Novavax have both reported positive data from Phase 3 clinical trials involving each of their investigational Covid-19 vaccines. Janssen says its vaccine was 72% effective in the U.S. and 66% effective overall at preventing moderate to severe Covid-19. The vaccine’s Phase 3 data also
Biologics
FDA has extended by three months the review of a Biogen BLA for aducanumab, indicated for treating Alzheimer’s disease. The updated user fee review action target date is 6/7. The extension was triggered by a Biogen-submitted “information request” response that included FDA-requested analyses and clinical data,
Devices
FDA has approved a Medtronic PMA for the DiamondTemp Ablation (DTA) system for treating patients with recurrent, symptomatic paroxysmal atrial fibrillation (AF) who have been unresponsive to drug therapy. The device is a temperature-controlled open-irrigated radiofrequency (RF) ablation system designed to deliver RF energy during ablations, Medtronic says,
Devices
FDA has classified as Class 1 a Penumbra recall of its Jet 7 Xtra Flex catheter due to its potentially becoming susceptible to distal tip damage during use. As a component of the Penumbra System with the Penumbra Aspiration Pump and Penumbra Aspiration Tubing, the Jet 7 Xtra Flex catheter
Drugs
FDA has cleared a Vertex Pharmaceuticals IND to proceed with a clinical trial for VX-880, an investigational stem cell-derived, fully differentiated pancreatic islet cell therapy to treat Type 1 diabetes. VX-880 has the potential to restore the body’s ability to regulate glucose levels by restoring pancreatic
Drugs
FDA has granted Ascentage Pharma an orphan drug designation for its novel Bcl-2 inhibitor, APG-2575, for treating patients with follicular lymphoma (FL). The company says FL is a heterogeneous disease and the second most common subtype of non-Hodgkin lymphoma (NHL) among adult patients in the U.S.
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) has released charts showing program metrics for the first quarter of the 2021 Fiscal Year. The post shows statistics on the number and percentage of core initial promotional material reviews completed in 45 days in each of the three months, percentage of