Drugs
The European Medicines Agency (EMA) says that Luxembourg and the Netherlands have been added to the list of states in the FDA-European Union (EU) mutual recognition agreement. An EMA announcement says FDA has confirmed the ability of regulators in the two countries to carry out current good manufacturing practice
Biologics
The FDA Tissue Reference Group (TRG) is launching a six-month TRG Rapid Inquiry Program (TRIP) to help manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps), including those stakeholders that market HCT/Ps to physicians or patients, obtain a rapid, preliminary, informal, non-binding assessment
Devices
FDA has released a draft guidance on “Mouse Embryo Assay for Assisted Reproduction Technology Devices.” The document outlines recommendations on conducting the mouse embryo assay (MEA) to support premarket submissions and lot release of assisted reproduction technology (ART) devices. The majority of ART devices directly or indirectly contact gametes (i.
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
Drugs
CDER Office of Biotechnology Products director Steven Kozlowski says FDA supports United States Pharmacopeia monograph standards for small molecule drugs, but believes that a mandatory monograph for biologics “would impede innovative technologies, as well as place unnecessary burdens on industry and on FDA reviewers.” Writing in an online CDER Conversation,
Drugs
FDA has accepted for priority review a Genentech supplemental BLA for Rituxan (rituximab) for combination use with glucocorticoids for treating granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children two years of age and older. GPA and MPA are rare, potentially life-threatening diseases affecting small and medium sized
Drugs
The HHS Inspector General (IG) says that most hospitals that use non-patient-specific compounded drugs obtain them from an outsourcing facility that is registered with FDA. In fact, an IG report says, 89% of hospitals that obtained non-patient-specific compounded drugs did so from outsourcing facilities, 9% obtained
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.
Devices
FDA has cleared an Applied BioCode 510(k) to permit the use of Roche’s MagNA Pure 96 Extraction System with the high throughput BioCode MDx-3000 and Gastrointestinal Pathogen Panel (GPP). Previously, BioCode’s devices were cleared for use on bioMerieux’s Nuclisens easyMAG extraction system. Applied BioCode says
Devices
FDA has cleared a CorMatrix Cardiovascular 510(k) for the Cor Patch, indicated for epicardial tissue support and repair in adult patients. The device is intended for epicardial support and repair of atria and/or the right and left ventricular walls of the heart that have been thinned or damaged
Drugs
Catalyst Pharmaceuticals is suing FDA in a Florida federal court, challenging the agency’s recent approval of Jacobus Pharmaceuticals’ Rezurgi for treating Lambert-Eaton Myasthenic Syndrome in pediatric patients. The company says its suit alleges that the approval violates multiple FDA labeling regulations, resulting in Rezurgi being misbranded. The suit
Drugs
Bloomberg News reports that a letter from a U.S. attorney describing settlement discussions with Novartis to resolve a six-year-old whistleblower suit alleging the company made illegal kickbacks to doctors to promote and use several of its drugs was accidentally made public for a short time before it
Drugs
An 11/8-11/16/18 FDA inspection at Spectrum Laboratory Products, Gardena, CA, found CGMP and other violations in the firm’s manufacturing of active pharmaceutical ingredients (API). A 6/4 Warning Letter says the CGMP violations were: * failing to transfer all quality or regulatory information received from the
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it strongly supports involvement of patients, their caregivers, and advocates in the rare disease drug development process and it commends FDA for the format and construct of a 4/29 public meeting it held on the subject. The association’s letter says
Drugs
CDER Office of Medical Policy health science policy analyst Lauren Milner says a new agency draft guidance on submitting documents using real-world data (RWD) and real-world evidence (RWE) to FDA for drugs and biologics is needed because the availability of such data and evidence has created interest within
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.
Drugs
Eli Lilly says data from its REWIND study, a cardiovascular (CV) outcomes trial involving diabetes drug Trulicity (dulaglutide), showed a significant 12% reduction in major cardiovascular events (MACE), a composite endpoint of non-fatal myocardial infarction (heart attack), non-fatal stroke or CV death. “REWIND data showed a consistent MACE
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.
Devices
GE Healthcare says artificial intelligence/machine learning (AI/ML) “is set to revolutionize healthcare. Device manufacturers are embracing AI/ML to create new medical devices and transform the way medical devices function in the healthcare environment.” Responding to an FDA discussion paper and request for feedback, the company says the
Devices
A 6/11-7/5/18 FDA inspection at OriGen Biomedical, Austin, TX, for Quality System Regulation and Medical Device Reporting violations in the firm’s manufacturing of dual lumen catheters, including the Reinforced Dual Lumen ECMO catheter. A just-released 12/20/18 Warning Letter says specific violations were:
Devices
FDA has cleared an EmCyte 510(k) for its PureBMC Supraphysiologic Concentrating System for the safe and rapid preparation of platelet concentrate and cell concentrate from a small sample of bone marrow aspirate through centrifugation. Bone marrow’s platelet and cell concentrate is the strongest autologous biologic prepared at the