FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Datascope Corp. Fairfield, NJ (9/11): FDA inspected the firm in June and cited GMP violations for medical devices. For example, the firm failed to maintain the requirements, including
Devices
FDA has cleared an Acessa Health 510(k) for the Acessa ProVu System, an integrated radiofrequency ablation, ultrasound visualization, and guidance mapping system for treating women with symptomatic uterine fibroids. The company says the device can treat nearly all sizes and locations of fibroids, including those outside the uterine cavity
Drugs
Endo International has recalled two lots of Robaxin (methocarbamol tablets, USP) 750mg tablets in 100-count bottle packs due to some products having incorrect daily dosing information on the label. A labeling error misstates the daily dose as “two to four tablets four times daily” rather than the correct dosage
Drugs
FDA says it has received reports of dosing errors and confusion with the “labeled strength expression” for certain compounded injectable products. “Conventional manufacturers label their injectable products with the strength per total volume as the primary and prominent expression of strength on the label, whereas some compounders label their injectable
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to an IND, NDA, BLA, or ANDA.” The document provides recommendations on the content and submission procedures for use-related risk analyses, human factors validation study protocols
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Adaptive Designs for Clinical Trials of Drugs and Biologics.” The document provides advice on the appropriate use of adaptive designs for clinical trials. It also describes the basic principles for designing, conducting, and reporting the results from an adaptive
FDA Policy/General
Federal Register notice: FDA has made available a draft guide entitled “Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.” The document provides advice to sponsors intending to simultaneously evaluate more than one investigational drug or more than one cancer type within the same
Devices
Oscor Inc. has recalled its TB Temporary Bipolar Pacing Lead (unshrouded 2 mm Pins Models) due to connectivity concerns. During the use of some TB Leads, featuring the 2mm unshrouded connectors, the cap housing may slide and potentially expose the connection wire, a recall notice says. “In some instances, this
Devices
Ventana Medical Systems has recalled (Class 1) multiple detection kits due to a potential for false negative results caused by reagent dispenser issues The detection kits use the company’s Flo-Lok III Dispenser and contain staining chemicals (reagents) used during immunohistochemistry lab tests. The dispensers release reagents that change
Devices
FDA says it is preparing a significant update to its guidance on “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” For example, the new draft guidance will “highlight the utility of providing customers and users with a ‘cybersecurity bill of materials’ – a list of commercial or off-
Devices
FDA 10/1 launched a revised Special 510(k) Pilot Program that aims to expand on the types of changes eligible for the program to improve the efficiency of 510(k) review. As part of this pilot, certain design or labeling changes that previously were reviewed as a traditional 510(
FDA Policy/General
Former Able Labs Quality Manager Debarred Federal Register notice: FDA denies a request for a hearing from Dilip Patel and is issuing an order to debar Patel for five years from providing services in any capacity to a person that has an approved or pending drug product application. 09/28/
FDA Policy/General
Federal Register notice: FDA has denied a request for a hearing from Dilip Patel and is issuing an order to debar Patel for five years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases its order on a finding
Drugs
FDA has issued a draft guidance entitled “Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Application.” The document provides recommendations on the contents of such submissions, and presents timelines for their review. It says that a comprehensive use-related risk analysis may
FDA Policy/General
Federal Register notice: FDA has issued a final order to reclassify single-use female condoms, renaming the device to “single-use internal condom,” a postamendments Class 3 device (regulated under product code MBU), into Class 2 (special controls) subject to premarket notification (510(k)). FDA is also amending the existing
Drugs
FDA has issued two new draft guidance documents — one on adaptive clinical trial designs and the other on master protocols — that propose important principles for modernizing clinical trials through these and similar approaches. “Adaptive clinical trials can give sponsors the flexibility to react to clinical evidence as it’s being
Drugs
FDA has approved Pfizer’s Vizimpro (dacomitinib), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. Approval was based on clinical
Drugs
Senators Orrin Hatch (R-UT) and Michael Bennet (D-CO) have introduced Making Objective Drug Evidence Revisions for New (MODERN) Labeling Act (S 3519) that would authorize FDA to modify outdated drug labels to reflect new evidence relevant to a drug and its use. “When a drug receives marketing approval
Devices
FDA has cleared a de novo request to permit the marketing of Adaptive Biotechnologies’ ClonoSEQ assay, a next-generation sequencing-based test for minimal residual disease (MRD) in patients with acute lymphoblastic leukemia or multiple myeloma. An FDA release says MRD is a measure of the amount of cancer cells
Drugs
FDA has released a final guidance entitled “Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” FDA regulations require an outsourcing facility to submit adverse event reports to FDA “in accordance with the content and format requirements established through guidance or regulation.
Devices
FDA commissioner Scott Gottlieb says the agency’s approach to digital health isn’t to regulate the everyday health and lifestyle uses of consumer devices, but rather to focus its resources on reviewing more sophisticated medical apps that sit on top of the general purpose hardware — the functions that have
Devices
FDA has issued a draft guidance, The Special 510(k) Program, that would update the Special 510(k) program to clarify existing policy and expand on the types of changes eligible for the program to improve the efficiency of 510(k) review. The agency says the update includes certain changes