Drugs
FDA has cleared a Pear Therapeutics 510(k) for its mobile medical application called reSET-O to help increase retention in an outpatient treatment program for individuals with opioid use disorder (OUD). The app is a prescription cognitive behavioral therapy intended to be used in addition to outpatient treatment under
Drugs
FDA has issued a safety communication reporting on preliminary findings and providing important information to hospitals and health care providers who use and reprocess duodenoscopes. Interim results from studies ordered by the agency show “higher-than-expected contamination rates after reprocessing, with up to 3% of properly collected samples testing
FDA Policy/General
Comments Sought on Real World Evidence Program Federal Register notice: FDA seeks comments on a CDER/CBER framework for implementing a program to evaluate the potential use of real-world evidence in regulatory decision making. 12/07/2018 Proposed Rule on De Novo Classification Process Federal Register proposed rule: FDA
FDA Policy/General
DEVICES FDA has cleared an EnsoData 510(k) for EnsoSleep, a software-only medical device used under the supervision of clinicians to analyze physiological signals and automatically score sleep study results. EnsoSleep is intended for use for the diagnostic evaluation by physicians to assess sleep quality and as an aid
Drugs
CDER deputy Center director for clinical science Bob Temple is being appointed to a new position at the Center — Office of New Drugs senior advisor. Temple has for many years worn simultaneous hats within CDER and his new role is being added to his deputy Center director responsibilities; he, however,
FDA Policy/General
Federal Register notice: FDA is seeking comments on a CDER/CBER framework for implementing a program to evaluate the potential use of real-world evidence in regulatory decision making. To view the notice, click here.
FDA Policy/General
Federal Register proposed rule: FDA is proposing to establish requirements for its medical device De Novo classification process. It also intends to establish procedures and criteria for de novo classification requests. The requirements seek to ensure the most appropriate classification of devices consistent with public health protection, as well as
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Developing and Labeling In Vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products.” The document includes factors for considering when broader labeling of a companion diagnostic would be appropriate. It notes that oncology companion
Drugs
AbbVie has stopped enrollment in the TAHOE trial, a Phase 3 study evaluating rovalpituzumab tesirine (Rova-T) as a second-line therapy for advanced small-cell lung cancer (SCLC). The halt in enrollment is based on a recommendation from an independent data monitoring committee that found a shorter overall survival
Drugs
CDER director Janet Woodcock has announced that Office of New Drugs (OND) deputy director Peter Stein has been selected as permanent director of the Office. Stein replaces John Jenkins, who retired two years ago. In Jenkins' absence, Woodcock assumed the role of OND director until a replacement was named.
Drugs
India’s Lupin Pharmaceuticals says FDA 11/26-12/4 inspections at the firm’s Mandideep location found “largely procedural” observations. Mandideep houses the company’s cardiovascular “Pril” active pharmaceutical ingredient (API) facilities, cephalosprorin API facilities, and cephalosporin solid oral dosage form facility. The company says the “Pril” API facilities
Drugs
FDA has approved Genentech’s Tecentriq (atezolizumab) for combination use with Avastin (bevacizumab), paclitaxel and carboplatin (chemotherapy) for the first-line treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. Approval is based on data from the Phase
Devices
FDA has cleared an iCAD Inc. 510(k) for its ProFound AI, a cancer detection software solution for digital breast tomosynthesis that relies on artificial intelligence (AI). The clearance is based on positive clinical results from a large reader study completed earlier this year. The research was performed with 24
Drugs
FDA says health care professionals and patients should not to use drug products intended to be sterile that were produced in an “inadequately designed processing room and distributed by Promise Pharmacy, Palm Harbor, FL, due to lack of sterility assurance.” During a recent inspection of Promise Pharmacy’s facility, agency
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry.” The document provides recommendations to control the risk of bacterial contamination of room temperature
Devices
FDA has cleared a Meridian Bioscience 510(k) for its new Alethia CMV Molecular Amplification Test. This assay is designed to detect congenital cytomegalovirus (cCMV) infection in newborns from a saliva sample. It is the first qualitative test in a molecular amplification format cleared for cCMV testing in newborns, the
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Environmental Impact Considerations” (OMB Control Number 0910-0322). To view the notice, click here.
Drugs
FDA has released a 2019 strategic framework under which it will continue to advance opportunities to use real-world data to improve regulatory decisions. FDA commissioner Scott Gottlieb says the strategic framework “is aimed at leveraging information gathered from patients and the medical community to inform and shape FDA’s
Devices
Medtronic says it initiated a field corrective action for its Puritan Bennett 980 ventilator series 9/19 that FDA has designated as a Class 1 recall. A company announcement says the corrective action is a software update to address customer feedback. It says the software updates the external USB drive
Drugs
FDA has issued a draft guidance, In Vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products, to describe considerations for development and labeling of companion diagnostic devices to support the indicated use of multiple drug or biologic oncology products when appropriate. The document includes factors
Drugs
FDA says Mylan is expanding its consumer-level nationwide recall to all lots of valsartan-containing products within expiry. The agency notice says the 104 additional lots include 26 lots of amlodipine and valsartan tablets in various strengths, 51 lots of valsartan tablets in various strengths, and 27 lots of
Devices
FDA commissioner Scott Gottlieb, CDRH director Jeffrey Shuren, and Gottlieb chief of staff Lauren Silvis say there is a need for a unified approach to the regulation of in vitro clinical tests to protect patient safety, support innovation, and keep pace with the rapidly evolving technology that is helping find