Drugs
A new study in JAMA suggests there is limited feasibility for the the idea of replicating clinical trials using real-world evidence (RWE). Researchers from numerous academic centers and industry examined clinical trials with human participants that were published in high-impact journals in 2017 and found “only 15% of
Drugs
FDA has cleared a Turn Therapeutics 510(k) for the Protego Antimicrobial Wound Dressing. The company says the single-use, sterile, antimicrobial gauze dressings are impregnated with Hexagen, Turn’s petrolatum-based wound care emulsion. Its broad-spectrum antimicrobial provides protection against bacteria, fungi, and yeasts, it says.
Drugs
There are seven inspection observations on the FDA-483 released by the agency following a 9/19-9/27 inspection at the Aurobindo finished drug manufacturing facility in Telangana, India. The observations were: * failing to thoroughly review any unexplained discrepancy and failure of a batch or any of its components
Drugs
FDA has released the FDA-483 issued following a 9/16-9/20 inspection at the Lupin API manufacturing facility in Maharashtra, India. The three inspection observations on the form were: * failing to thoroughly review any unexplained discrepancy whether or not the batch has already been distributed; * batch production and
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act” (OMB Control Number 0910-0827). Outsourcing facilities are required to register with FDA and submit regular
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings-Labeling Considerations.” The document addresses labeling for devices containing lubricious coatings used in the vasculature. It also provides recommendations for information to be included in the device labeling for consistency
Biologics
FDA says its scientists have developed two candidate vaccine viruses that may be used as the starting material for producing inactivated influenza vaccines. The candidate vaccine viruses protected lab animals against a highly pathogenic strain of Influenza A (H7N9), a potentially pandemic virus, an agency statement says. The candidates are
Devices
FDA has cleared a Sky Medical Technology 510(k) for its geko device for stimulating the calf muscles to prevent venous thrombosis in non-surgical patients at risk for venous thromboembolism (VTE). Previously, the device was cleared for immediate post-surgical stimulation of calf muscles to prevent VTE, increasing blood
Drugs
FDA has released a new Biosimilar User Fee Act (BsUFA) performance dashboard on the FDA-Track reporting Web site. An agency notice says the dashboard provides “more user-friendly and transparent information for the BsUFA performance metric goals.” The dashboard provides a concise, interactive, and visual presentation of data in
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Coronary, Peripheral, and Neurovascular Guidewires — Performance Tests and Recommended Labeling.” The document provides recommendations for the information and testing that should be included in premarket submissions for these guidewires. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination.” The document describes an optional streamlined submission process to determine whether use of an investigational in vitro diagnostic in an oncology clinical trial is considered
Drugs
FDA has granted a de novo clearance for OraSure Technologies’s OraQuick Ebola Rapid Antigen Test to detect Ebola virus antigens (proteins) in human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola. “The test provides a rapid, presumptive diagnosis that
Drugs
The U.S. Pharmacopeia commends FDA for its draft guidance to enhance the utility and usability of the inactive ingredient database (IID) and says it has seen marked enhancements in the document. “We believe the information presented in the draft guidance will help reduce discrepancies between the IID and USP-
Devices
The Justice Department says UTC Laboratories (RenRX), a genetic testing company, and three of its principals will pay $42.6 million to resolve allegations that they violated the False Claims Act by paying kickbacks in exchange for laboratory referrals for pharmacogenetic testing and for furnishing and billing for tests that
Devices
ICU Medical has recalled certain lots of Plum and Sapphire Microbore Infusion Sets with inline filters due to the potential for fluid leaks through air vents on the inline filters. To date, the company has not received any adverse event reports related to the issue, a recall notice says. Fluid
Drugs
CDER director Janet Woodcock and CBER director Peter Marks review in a New England Journal of Medicine editorial some of the regulatory, ethical, and other considerations that arise with true individualized therapies. After describing cases in which single patients were treated with an individualized gene therapy, Woodcock and Marks ask
Devices
FDA has issued a guidance, Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings—Labeling Considerations, to provide recommendations for information to be included in the device labeling as submitted in PMAs or 510(k)s for Class 2 and 3 devices. The document is intended to enhance the consistency
Drugs
FDA has issued a guidance, Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination, describing an optional streamlined submission process for determining whether use of an investigational in vitro diagnostic (IVD) in a clinical trial for an oncology therapeutic is considered significant risk, nonsignificant risk,
Devices
A recent FDA policy guidance on medical device software says the agency will exercise enforcement power over three distinct types of software functions, one of which is specifically directed at mobile applications — functions that transform a mobile platform into a regulated medical device by using attachments, display screens, or sensors
Devices
FDA has cleared a Beckman Coulter 510(k) for the DxA 5000 total laboratory automation system. The device is intended to help eliminate preanalytical errors by automatically detecting patient tube parameters such as sample identification, tube type, orders pending and tube weight, the company says. It is designed to focus
FDA Policy/General
Federal Register notice: FDA has announced an 11/12 public workshop on “Advancing the Development of Pediatric Therapeutics (ADEPT6): Pediatric Clinical Trial Endpoints for Rare Diseases with a Focus on Pediatric Patient Perspectives.” The workshop is scheduled to discuss pediatric patient-specific engagement in developing clinical trial endpoints for rare
FDA Policy/General
Federal Register notice: FDA has announced that it has issued a material threat medical countermeasure priority review voucher to Bavarian Nordic for recently approved Jynneos (smallpox and monkeypox vaccine, live, non-replicating). The agency determined that the product met criteria for the priority review voucher because it is intended to