Drugs
As part of its response to efforts to rein in prescription drug costs, FDA has issued two updated final guidances to provide greater clarity about its thinking and recommendations for certain medical product communications. The first guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities—Questions
Drugs
Based on disappointing data, Eli Lilly and AstraZeneca are discontinuing global Phase 3 clinical trials of lanabecestat, an oral beta secretase cleaving enzyme (BACE) inhibitor for treating Alzheimer’s disease. Recommendations by an independent data monitoring committee concluded that both the AMARANTH trial, in early Alzheimer’s patients, and the
Drugs
A 9/1-9/11/17 FDA inspection at Taiwan Biotech Company, Taoyuan City, Taiwan, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 5/31 Warning Letter. Specific violations cited in the letter were: * failing to establish an adequate system for monitoring
Biologics
Public Citizen says HHS has made substantive changes to the protocol and consent forms for a National Institutes of Health clinical trial that the advocacy group said had potentially serious ethical violations. In an 8/1/17 letter, Public Citizen called for immediate suspension of the Myocardial Ischemia and Transfusion
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following each letter. Taiwan Biotech Company, Taiwan, Republic of China (5/31): FDA inspected the firm’s drug manufacturing facility 9/2017 and cited significant GMP
Drugs
The DC federal court has ordered FDA to grant seven years of orphan drug exclusivity to Eagle Pharmaceuticals’ Bendeka (bendamustine hydrochloride injection), described as a liquid, low-volume, and short-time 10-minute infusion formulation of bendamustine hydrochloride. The company says that due to the court’s ruling, FDA will
FDA Policy/General
Federal Register notice: FDA has published the following list of recent OMB-approved information collections: * Biological Products—General Records and Postmarket Adverse Experience Reporting * Guidance for Industry: Fast Track, Drug Development Programs—Designation, Development, and Application Review * Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e)
FDA Policy/General
Federal Register notice: FDA has announced the renewal of its Drug Safety and Risk Management Advisory Committee for an additional two years. The new charter will be in effect until 5/31/2020. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced the renewal of the Peripheral and Central Nervous System Drugs Advisory Committee for an additional two years. The new charter will be in effect until 6/4/2020. To view the notice, click here.
Devices
FDA has cleared an Optovue 510(k) for its AngioAnalytics, an optical coherence tomography angiography (OCTA) blood vessel measurement technology to help clinicians manage diseases that cause progressive blindness. The company also received 510(k) clearance for its three-dimensional projection artifact removal (3D PAR) software, which is designed to
Drugs
FDA has approved an Amgen supplemental NDA to add positive overall survival data from the Phase 3 ASPIRE trial to the prescribing information for Kyprolis (carfilzomib). The new data show that Kyprolis, lenalidomide and dexamethasone significantly reduced the risk of death by 21% and extended overall survival by 7.9
FDA Policy/General
Federal Register notice: FDA has determined that Mutamycin (mitomycin) injectable, 5mg/vial and 20mg/vial, was not withdrawn for reasons of safety or effectiveness. The determination will allow the agency to approve ANDAs that reference the products if all other legal and regulatory requirements are met. To view the notice,
FDA Policy/General
Federal Register notice: FDA has announced the renewal of its Pharmacy Compounding Advisory Committee for an additional two years. The new charter will be in effect until 5/25/2020. To view the notice, click here.
Devices
FDA has cleared a Centinel Spine 510(k) to market its FLX Platform of integrated interbody and non-integrated interbody fusion devices. The 3D-printed, all-titanium devices feature a combination of solid and porous radiolucent sections designed to reduce mechanical stiffness and improve visibility, compared to solid titanium implants,
Drugs
FDA has approved a Cellenkos IND to proceed with a Phase 1 clinical trial of CK0801, third-party cord blood-derived regulatory T cells, in patients with bone marrow failure syndrome including aplastic anemia, myelodysplastic syndrome and myelofibrosis. The trial of CK0801 will begin in the third quarter at the
FDA Policy/General
Mutamycin Not Withdrawn Over Safety/Efficacy: FDA Federal Register notice: FDA determines that Mutamycin (mitomycin) injectable, 5mg/vial and 20mg/vial, was not withdrawn for reasons of safety or effectiveness. 06/11/2018 Correction on Product Classification Proposed Rule Federal Register notice: FDA corrects a 5/15 proposed rule to
Devices
FDA has cleared an Edap TMS 510(k) for its Focal One device for ablating prostate tissue. The high-intensity focused ultrasound device is the “first medical apparatus designed specifically for focal treatment of the prostate,” the company says. “Focal One fuses MR and 3D biopsy data with real-time
FDA Policy/General
Federal Register notice: FDA has corrected a 5/15 proposed rule to amend its regulations concerning the classification of products as biological products, devices, drugs, or combination products, and their assignment to agency centers for premarket review and regulation. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 6/27 public workshop entitled “Development of Inhaled Antibacterial Drugs for Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis.” The workshop is scheduled to discuss clinical trial design challenges and future considerations for inhaled antibacterial products to treat cystic fibrosis (CF) and non-CF
FDA Policy/General
Federal Register notice: FDA has classified the in vivo cured intramedullary fixation rod into Class 2 (special controls). The action was in response to a 2016 request by IlluminOss Medical for a De Novo classification of the IlluminOss Photodynamic Bone Stabilization System. The agency has identified the rod as a
Drugs
Federal Register notice: FDA has announced the renewal of the Pulmonary-Allergy Drugs Advisory Committee for an additional two years. The new charter will be in effect until 5/30/2020. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted a proposed extension for a collection of information on Medical Device Reporting: Electronic Submission Requirements (OMB Control Number 0910-0437). To view the notice, click here.