Drugs
An FDA biomarker qualification program online post says that a biomarker context of use (CoU) “is a statement that describes the manner and purpose of use for the biomarker in drug development. The supporting data and analyses submitted with the biomarker qualification submission determine the acceptability of the qualified CoU.
FDA Policy/General
Federal Register notice: FDA has announced fiscal year 2018 rates for generic drug user fees. Application fees are: ANDA ($171,823) and Drug Master File ($47,829). Facility fees are: domestic API facility ($45,367), foreign API facility ($60,367), domestic finished dosage facility ($211,087), foreign finished dosage facility
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Hetero Labs Limited Hyderabad, India (8/15): FDA inspected the firm’s facility 12/2016 and documented significant GMP violations for finished pharmaceuticals. For example, the firm failed to
Devices
FDA has cleared a Leica Microsystems 510(k) for its FL560 fluorescence microscope filter for visualizing cerebrovascular blood flow in conjunction with the dye fluorescein. “When integrated into a M530 OH6 neurosurgical microscope, FL560 fluorescence provides real-time, high-contrast visualization of both cerebral anatomy in native color and fluorescent
Drugs
FDA has granted UroGen Pharma a fast track designation for MitoGel and its use in treating patients with low-grade upper tract urothelial carcinoma. The product is currently being evaluated in the ongoing, single-arm, open-label, pivotal Phase 3 OLYMPUS clinical trial. There are currently no drugs approved by
Devices
CDRH Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) director Alberto Gutierrez has announced he will retire at the end of September. Gutierrez joined FDA in 1992 as a CBER reviewer for vaccine adjuvants and method development for determination of the purity and structure of vaccine components. In
Drugs
FDA has accepted for priority review a La Jolla Pharmaceutical Co. NDA for the investigational drug LJPC-501 (angiotensin II) for treating hypotension in adults with distributive or vasodilatory shock who remain hypotensive despite fluid and vasopressor therapy. The agency has set a user fee review action target of 2/
Devices
FDA has approved an Ortho Clinical Diagnostics BLA for the Ortho Sera blood grouping reagents designed for extended phenotype testing with the ID-Micro Typing System Gel Card technology. “During pre-transfusion testing, labs routinely encounter patient samples that require extended antigen typing for blood group system antigens beyond those
Drugs
Federal Register notice: FDA has announced a 12/7 Bone, Reproductive and Urologic Drugs Advisory Committee meeting. Panel members will discuss appropriate patient selection criteria and clinical trial design features, including acceptable endpoints, for demonstrating clinical benefit for drugs intended to treat interstitial cystitis and bladder pain syndrome. The committee
FDA Policy/General
FDA Warning Letters issued to medical product makers are significantly down in 2017, and several agency watchers are worried that president Donald Trump’s anti-regulation stance could be behind the drop. Letters posted on FDA’s Web site show a 30% decline from the eight-year average of the
Devices
FDA says Cook Medical has initiated a correction to its “instructions for use” for the Zenith Alpha Thoracic Endovascular Graft. The correction removes the indication for blunt thoracic aortic injury or “transection” of the aorta because Cook has received an increase in reports of graft thrombosis and occlusion with these
FDA Policy/General
Federal Register notice: FDA has announced a 10/12 Cellular, Tissue, and Gene Therapies Advisory Committee meeting. Panel members are scheduled to discuss and make recommendations on the safety and effectiveness of a Spark Therapeutics BLA for voretigene neparvovec, indicated for treating patients with vision loss due to confirmed biallelic
Devices
CDRH has sent out a letter to medical device establishments to provide information about device user fees, including fee rates and payment procedures, for fiscal year 2018 (FY18), which begins 10/1.The letter notes that the annual establishment registration fee must be paid between 10/1 and 12/31.
Drugs
On FDA’s behalf, U.S. marshals 8/25 seized five vials of Vaccinia Virus Vaccine (live) belonging to StemImmune Inc. (San Diego, CA), a vaccine that is reserved only for people at high risk for smallpox, such as some members of the military, but administered to patients at the
FDA Policy/General
FDA has put in place new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine. While stem cell research and regenerative medicine hold much promise, some clinics and “unscrupulous actors” are “exploiting the uncertainty” by making “deceptive, and sometimes corrupt, assurances to patients
FDA Policy/General
MilliporeSigma has entered into an agreement to acquire Natrix Separations, an Ontario, Canada-based provider of hydrogel membrane products for single-use chromatography, for an indisclosed amount. The acquisition is intended to complement MilliporeSigma’s efforts to drive next-generation bioprocessing, ultimately enabling faster, more efficient technology for customers. CSL
FDA Policy/General
Draft Guide on Drug Supply Trading Partners Federal Register notice: FDA makes available a draft guidance entitled “Identifying Trading Partners Under the Drug Supply Chain Security Act.” 08/25/2017 Guidance on Oncology Drugs for Companion Animals Federal Register notice: FDA makes available a guidance for industry #237 entitled “Oncology
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Identifying Trading Partners Under the Drug Supply Chain Security Act.” The document is intended to assist industry and state and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the Drug
Devices
FDA has told Medizone International that it should proceed to market through the de novo classification pathway for its novel AsepticSure disinfection system. The company says it intends to support its application with data demonstrating AsepticSure’s safety and efficacy profile and low-risk nature. The portable device is intended
Drugs
FDA has released more details on a CDER and ORA “concept of operations” agreement to integrate facility evaluations and inspections for human drugs (see earlier story). The agreement outlines responsibilities and the workflow for pre-approval, post-approval, surveillance, and for-cause inspections at domestic and international facilities. It will
Drugs
FDA has approved Kedrion Biopharma and Kmada Ltd.’s KedRab [rabies immune globulin (human)] for passive, transient post-exposure prophylaxis of rabies infection, when given immediately after contact with a rabid animal. The human rabies immunoglobulin (HRIG) should be administered concurrently with a full course of rabies vaccine, according to
FDA Policy/General
Federal Register notice: FDA has made available a guidance for industry #237 entitled “Oncology Drugs for Companion Animals.” The document provides recommendations for sponsors of investigational oncology drugs for use in companion animals (e.g., dogs, cats, and horses), discusses the contents of a new animal drug application for certain