Drugs
CBER director Peter Marks says FDA and the National Institutes of Health have released a finalized template for investigators to use when organizing clinical trial protocols. Writing in an FDA Voice blog post, Marks says issuance of the template “is likely to contribute important efficiencies to the process of protocol
Devices
Medtronic principal litigation counsel Max Heerman and Greenberg Traurig shareholder Daniel Smulian say that medical device company representatives should continue to be allowed in operating rooms because they “are a constructive presence, providing technical support to doctors and their staffs, and improving outcomes for patients.” Writing in a Washington Legal
Devices
FDA is warning users of Medtronic’s NavLock Tracker device not to use non-Medtronic surgical stereotaxic navigation instruments due to the potential for increased adverse events. The NavLock Tracker, an accessory to Medtronic's StealthStation Surgical Navigation System, enables navigation of instrumentation used during spinal fusion and interbody
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection for “Institutional Review Boards (IRBs) — 21 CFR 56.115 — OMB Control Number 0910–0130.” IRBs are required to create and maintain records describing their operations, and make the records available for FDA inspection when requested. Such records include: written
Drugs
FDA has approved a Takeda Pharmaceutical Co. NDA for Alunbrig (brigatinib) for treating patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer who have progressed on or are intolerant to crizotinib. The accelerated approval was based on tumor response rate and duration of response shown in a
FDA Policy/General
FDA would see a $39 million boost in its fiscal year (FY) 2017 spending under a budget bill lawmakers unveiled Monday. Under the bill, the agency would receive $2.759 billion in discretionary funding, a little over 1% increase over the FY 2016 enacted level. Total FDA funding, including user
FDA Policy/General
Federal Register notice: FDA has announced that two information collection proposals — “Establishment Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution” and “Blood Establishment Registration and Product Listing” have been approved by the Office of Management and Budget (OMB). The information collections and have been assigned OMB
Devices
FDA has cleared a Roche 510(k) for its cobas e 801 module for use on the cobas 8000 modular analyzer system. The module offers “greater testing efficiency, superior reagent management” and fast turnaround time for critical diagnostic tests, according to the company. “The cobas e 801 module almost doubles
FDA Policy/General
Federal Register notice: FDA has announced the availability to license an agency invention for “Solid-Phase Purification of Synthetic DNA Sequences,” a high-throughput method for purifying full-length phosphorothioate and native DNA sequences. The method comprises a modified silica gel that enables capture of DNA sequences functionalized with a
Drugs
FDA has granted accelerated approval to AstraZeneca for Imfinzi (durvalumab) for treating patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. The agency also
Devices
FDA has cleared a Coapt 510(k) for its Complete Control System, described as an intuitive system for controlling advanced prosthetic arms. The company calls it the “first and only myoelectric pattern recognition system to be cleared for marketing in the United States... Its plug-and-play hardware seamlessly integrates
Drugs
Sanofi and Regeneron Pharmaceuticals have resubmitted their BLA for sarilumab, an investigational interleukin-6 receptor antibody for treating adult patients with moderately to severely active rheumatoid arthritis. In 10/2016, FDA sent the companies a Complete Response Letter on their BLA, citing certain deficiencies identified during a routine good manufacturing
FDA Policy/General
LabCorp has acquired the assets of the Mount Sinai Health System Clinical Outreach Laboratories, and LabCorp is now available to provide comprehensive laboratory services to physicians and patients that previously used the outreach laboratory. Xenon Pharmaceuticals has acquired from 1st Order Pharmaceuticals XEN1101, a potassium channel modulator for the potential
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension on “Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions — 21 CFR Part 60 — OMB Control Number 0910–0233.” Such petitions should provide sufficient facts, including dates if possible, to merit an investigation by FDA
Drugs
Senator Patrick Leahy (D-VT) has introduced legislation to combat anticompetitive practices used by some brand-name pharmaceutical and biologic companies to block lower-cost generic drugs from entering the market. The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act aims to put an end to brand-name
Drugs
FDA has released a three-item Form 483 after an inspection at Lupin’s Goa, India drug manufacturing facility found GMP problems. For example, the agency said the firm failed to thoroughly review any unexplained discrepancy and the failure of a batch to meet any of its specifications. The company
FDA Policy/General
Federal Register notice: FDA has announced a 5/18 joint Pediatric Advisory Committee and Pediatric Ethics Subcommittee meeting to discuss a referral by an Institutional Review Board of a clinical investigation that involves children and FDA-regulated products. The clinical investigation is entitled “A Double-Blind, Placebo-Controlled, Multi-Center
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Good Laboratory Practice Regulations for Nonclinical Studies — 21 CFR Part 58 OMB Control Number 0910–0119.” The regulations specify minimum standards for proper safety testing and they contain sections on facilities, personnel, equipment, standard operating procedures, test
Devices
FDA has launched a new medical device Web page, “Use of Symbols in Labeling,” to assist the public in understanding the Use of Symbols in Labeling final rule that became effective 9/2016. The rule permits the use of symbols in device labeling without adjacent explanatory text (typically called “stand-
Devices
FDA has cleared a Faxitron 510(k) for the LOCalizer, a wireless radiofrequency identification (RFID) breast lesion localization system. The device uses a non-radioactive, proprietary tag as a marker to enable surgeons to remove the correct area of breast tissue during a procedure. The tag can be implanted up
Drugs
FDA has approved a Radius Health NDA for Tymlos (abaloparatide) injection for treating postmenopausal women with osteoporosis at high risk for fracture. In such women, Tymlos reduces the risk of vertebral and nonvertebral fractures. Approval was based on data from an 18-month trial called ACTIVE and the first six
FDA Policy/General
Federal Register notice: CDER and CDRH have announced a two-day (5/9-10) public conference entitled “FDA Small Business and Industry Assistance Regulatory Education for Industry (REdI) Spring Conference.” The conference is intended to address questions from small manufacturers of drug or medical devices who want to learn about