Biologics
CBER’s Office of Compliance and Biologics Quality/Division of Inspections and Surveillance says it entered 51,229 deviation reports into the Biological Product Deviation database in FY 2016, up 10% from the number of reports entered in FY 15. Blood and source plasma establishments submitted 4,546 more reports
Devices
FDA has cleared a Thermo Fisher Scientific 510(k) for its microbroth dilution plate for antimicrobial susceptibility of Gram negative organisms, including two of the latest novel compounds — ceftolozane/tazobactam and ceftazidime/avibactam. The plate enables microbiology laboratories to measure true minimum inhibitory concentration (MIC) values of 24 antimicrobials, which
Drugs
FDA has released its plan to eliminate the existing orphan drug designation backlog and ensure timely response to all new designation requests with firm deadlines. An agency news release (contains link to modernization plan) says the plan comes one week after commissioner Scott Gottlieb committed in Senate subcommittee testimony to
FDA Policy/General
Federal Register notice: FDA has made available a revised draft guidance on “Current Good Manufacturing Practice for Medical Gases.” The document is expected to reduce the regulatory compliance burden for the medical gas industry by providing clear, up-to-date, detailed recommendations regarding GMP issues that have been the subject
FDA Policy/General
Federal Register notice: FDA has announced a 9/13 public workshop entitled “Antimicrobial Susceptibility and Resistance: Addressing Challenges of Diagnostic Devices” to discuss potential scientific and regulatory challenges associated with developing traditional antimicrobial susceptibility testing (AST) devices and devices that detect antimicrobial resistance markers by molecular or novel diagnostic technologies,
Devices
The Office of the National Coordinator says that in the event of a ransomware attack involving a healthcare facility’s medical devices, FDA should be contacted at its emergency number 1-866-300-4374. Reports of impact on multiple devices should be aggregated on a system/facility level, it says.
Drugs
FDA has cleared a Varian Medical Systems 510(k) for its Halcyon system for cancer treatment. The company says the device is designed to simplify and enhance most aspects of image-guided volumetric intensity modulated radiotherapy. “With its streamlined workflow, the system only requires nine steps from the start to
Drugs
FDA has released the FDA-483 issued following a 6/12-6/16 inspection at Dr. Reddy’s Laboratories, Andhra Pradesh, India. The violation noted on the form involved a finding that testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to
FDA Policy/General
Federal Register notice: FDA is seeking comments on a statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for original BLAs. The program is part of agency performance commitments under the proposed reauthorization of the Biosimilar User Fee Act. As part of these commitments,
Devices
Former FDA associate commissioner Joshua Sharfstein says the controversy involving power morcellators and the risk of unexpected uterine sarcoma “serves as a reminder that every procedure and medical device has the potential for both benefit and harm.” Writing in the Journal of the American Medical Association, Sharfstein and two other
Drugs
FDA has published the FDA-483 issued following a 6/12-6/16 inspection at Lupin Limited, Madhya Pradesh, India. Observations shown in the form were: * failing to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed; * failing to establish control procedures that monitor the
Drugs
FDA has granted Marinus Pharmaceuticals an orphan drug designation for ganaxolone for treating CDKL5 Disorder. The drug is currently being evaluated in a Phase 2 clinical trial in children with CDKL5 Disorder, which affects children at an early age and causes difficult-to-control seizures and neuro-developmental impairment. Ganaxolone,
Devices
FDA has allowed the marketing of Beckman Coulter’s ClearLLab Reagents (T1, T2, B1, B2, M), the first agency-authorized test for use with flow cytometry to aid in detecting several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome and myeloproliferative neoplasms. “Laboratories and
Drugs
APCO Worldwide says that while the biopharmaceutical industry’s reputation remained stable since last year, there is little reason to believe it will continue in a positive direction without a shift in engagement strategies. The firm’s Return our Reputation study says the central industry vulnerability is a doubt about
Drugs
FDA is publishing a Federal Register notice soliciting comment on a statement of work for assessing the Program for Enhanced Review Transparency and Communication for 351(k) biosimilar applications. The program is part of agency performance commitments under the proposed reauthorization of the Biosimilar User Fee Act for 2018-2022.
Drugs
[Correction *] Starting early next year, FDA will begin encouraging a voluntary quality metrics reporting program to calculate three metrics, according to industry representatives presenting (see slides) at a Drug Information Association (DIA) session in Chicago 6/21. An earlier posting of this report last week erroneously attributed this information to
FDA Policy/General
Researchers at the Oregon Health & Science University and Memorial Sloan Kettering Cancer Center say there are questions raised by Incyte’s partnership with the television soap opera General Hospital over a story line involving a character diagnosed with polycythemia vera (PV) and a blood clot. Writing in the Journal
Drugs
The Clinical Trials Transformation Initiative (CTTI) has released recommendations and tools to provide a pathway for using information gathered from mobile technologies to accelerate development and evaluation of new therapies. The recommendations and tools are designed to help diverse stakeholders identify and develop novel endpoints based on data from mobile
Devices
FDA has cleared a Quidel 510(k) for the Sofia RSV Fluorescent Immunoassay to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid detection of respiratory syncytial virus infections in nasopharyngeal swab and nasopharyngeal aspirate/wash specimens taken directly from symptomatic pediatric patients. The company says Sofia
Drugs
FDA has released a draft guidance on “Current Good Manufacturing Practice for Medical Gases.” The agency says the document was mandated under the FDA Safety and Innovation Act to provide additional guidance on GMP regulations to reduce the regulatory compliance burden for the medical gas industry. It is intended to
FDA Policy/General
The House Appropriations Subcommittee on Agriculture/FDA has advanced to the full committee an FDA funding bill that provides almost $2.8 billion ($4.473 billion when excluding tobacco user fees) in direct budget authority for fiscal year 2018, which is the same level as FY 2017. In his opening
Drugs
FDA acting chief scientist Luciana Borio has accepted a one-year detail with the National Security Council to assist with medical and biodefense preparedness. CDER Office of Medical Policy acting director Denise Hinton is being reassigned to the permanent position of deputy chief scientist, and she has agreed to serve