FDA Policy/General
DEVICES FDA has cleared an AnthroTronix 510(k) for its computerized cognitive test battery DANA, which is intended to provide clinicians with objective measurements of reaction time (speed and accuracy) to aid in the assessment of an individual’s medical or psychological state. The phone and tablet based app is
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Testing for Biotin Interference in In Vitro Diagnostic Devices.” The document provides FDA’s recommendations on the testing for interference by biotin on the performance of in vitro diagnostic devices. It is intended to help device developers and clinicians
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 12 ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed and requested their withdrawal. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is requesting that any consumer organizations interested in participating in selecting voting or nonvoting consumer representatives to serve on its advisory committees or panels notify the agency in writing. FDA is also requesting nominations for voting or nonvoting consumer representatives to serve on advisory committees for
FDA Policy/General
Federal Register notice: FDA has announced a 7/31 Psychopharmacologic Drugs Advisory Committee meeting. Panel members are scheduled to discuss an Intra-Cellular Therapies NDA for lumateperone tosylate capsules, indicated for treating schizophrenia. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 7/25 Arthritis Advisory Committee meeting to discuss a Boehringer Ingelheim supplemental NDA for Ofev (nintedanib) capsules, indicated for treating systemic sclerosis-associated interstitial lung disease. The panel will discuss whether the application provides substantial evidence of efficacy for the proposed indication. To
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Mouse Embryo Assay for Assisted Reproduction Technology Devices.” The document provides recommendations on conducting a mouse embryo assay to support premarket submissions and lot release of assisted reproduction technology devices. To view the notice, click here.
FDA Policy/General
An FDA safety alert warns about infections with multi-drug resistant organisms after patients received investigational fecal microbiota for transplantation (FMT), including one patient death. “Two immunocompromised adults who received investigational FMT developed invasive infections caused by extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E.coli),” the alert says.
FDA Policy/General
Federal Register notice: FDA has published a list of information collections that have been recently approved by OMB. They are: * Healthcare Professional Survey of Professional Prescription Drug Promotion * Formal Dispute Resolutions; Appeals Above the Division Level * FDA’s Research and Evaluation Survey for the Public Education Campaign on Tobacco Among
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Reporting Associated With Designated New Animal Drugs for Minor Use and Minor Species — 21 CFR Part 516” (OMB Control Number 0910-0605). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is publishing a list of information collections that have been approved by OMB. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined that Johnson & Johnson’s Nizoral (ketoconazole) topical cream 2% was not withdrawn from sale for safety or effectiveness reasons. The determination allows FDA to continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. Nizoral
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Investigational Device Exemptions Reports and Records” (OMB Control Number 0910-0078). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of six ANDAs from multiple applicants after they notified the agency in writing that the products were no longer marketed and requested that they be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has reopened the comment period on a 2/17 Federal Register notice entitled “Quality Considerations for Continuous Manufacturing; Draft Guidance for Industry; Availability.” The agency is allowing interested parties additional time to submit comments, which are now due by 8/10. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has announced an 11/18 The public workshop entitled “Development of Best Practices in Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Clinical Pharmacology Regulatory Decision-Making.” The workshop is intended to discuss best practices and evidentiary criteria for using such modeling approaches; share experiences and cases
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “FDA Safety Labeling Change — Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act” (OMB Control Number 0910-0734). FDA regulations permit the agency to order labeling changes if it becomes aware of
FDA Policy/General
Workshop on Generating Real-World Evidence Federal Register notice: FDA announces a 7/12 public workshop entitled “Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes.” 06/07/2019 Nonalcoholic Steatohepatitis Drug Development Guide Federal Register notice: FDA makes available a draft guidance entitled “Nonalcoholic Steatohepatitis with
FDA Policy/General
DEVICES Medtronic has received approval from FDA for the Prestige LP Cervical Disc System for treating single-level cervical disc disease (radiculopathy and/or myelopathy). Quidel Corp. has received FDA clearance to market its AmpliVue GAS Assay for the qualitative detection of Group A β-hemolytic Streptococcus (Streptococcus pyogenes) nucleic
FDA Policy/General
Sandoz has agreed to pay $12.64 million to settle allegations it misrepresented drug pricing data to the Medicare program. HHS Office of Inspector General (OIG) says the settlement is the largest ever entered into under its drug price reporting civil monetary penalty (CMP) authority. OIG alleged that between 1/
FDA Policy/General
Federal Register notice: FDA has announced a 7/12 public workshop entitled “Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes.” Convened by Duke University’s Margolis Center for Health Policy and supported by a cooperative agreement with FDA, the workshop is intended to bring the stakeholder
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment.” The document provides the agency’s current recommendations on important components of a drug development program for treating this condition. It focuses on enrollment criteria, trial design, efficacy endpoints, and