Drugs
Sen. Charles Grassley (R-IA) says the Justice Department “deserves credit for bringing a case over the price fixing of generic drugs. Consumers pay the price for criminal conduct, and the Justice Department is doing its job to protect the public from such conduct.” His statement came in response to
FDA Policy/General
Federal Register Notice: FDA has asked for comments on an information collected extension related to its guidance on “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.” The document describes FDA’s interpretation on how determines if: (1)
FDA Policy/General
Rep. Tom Price (R-GA), the doctor who has been nominated as HHS secretary, has worked hard during his time in Congress to keep federal dollars flowing to his most generous campaign donors, according to a Kaiser Health News report. The report says a review of the congressman’s records
FDA Policy/General
Federal Register Notice: FDA has made available a draft guidance entitled “Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers.” The document addresses questions about FDA’s expectations for annual reporting by prescription drug wholesale distributors and third-party logistics providers. To view the
FDA Policy/General
Pharmaceutical Research and Manufacturers of America (PhRMA) says that FDA’s use of character-space-limited social media platforms such as Twitter “should set the industry standard for appropriate utilization of these media.” Responding to an agency research proposal involving character-space-limited online prescription drug communications, PhRMA says it
Devices
FDA has cleared a Teleflex 510(k) for its Arrow VPS Rhythm Device with Optional TipTracker Technology that is intended to provide electrocardiogram-based tip confirmation. The device helps in placement and confirmation of a catheter tip in the superior vena-cava-cavoatrial junction, and it may be used with
Drugs
The owner of a Utah drug distribution company has pled guilty in southern New York federal court to fraudulently distributing more than $100 million worth of prescription drugs obtained on a nationwide black market. Randy Crowell “perverted for profit a health care system designed to get safe and effective medications
Drugs
PTC Therapeutics says it plans to file in protest an NDA for Translarna (ataluren) for treating nonsense mutation Duchenne muscular dystrophy (DMD) this quarter. The move follows the company’s loss in October of an appeal after receiving a refuse-to-file letter (see story) issued by the Division of
Biologics
FDA has accepted for priority review a Genentech supplemental BLA for Tecentriq (atezolizumab) for treating people with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin chemotherapy, and are either previously untreated (first-line) or have disease progression at least 12 months after receiving chemotherapy before surgery (neoadjuvant)
Drugs
Data integrity was a top concern for FDA In 2016, according to an analysis by the law firm Mintz Levin. “FDA focused on technical compliance issues that can pose risks to the safety of regulated products, such as data integrity within drug and device manufacturing facilities and unsanitary conditions in
FDA Policy/General
Federal Register Notice: FDA has extended the comment period for a revised draft guidance entitled “Submission of Quality Metrics Data” that was published in the 11/25/2016 Federal Register. The document describes FDA’s plans for an initial, voluntary phase of its quality metrics program that will allow the
FDA Policy/General
Federal Register Notice: FDA has announced a 3/23 Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting. The panel will discuss and make recommendations on clinical information related to a de novo request for the Claret Medical’s Sentinel Cerebral Protection System, an embolic protection device intended
FDA Policy/General
Federal Register Notice: FDA has announced an Emergency Use Authorization issuance to ELITechGroup Molecular Diagnostics for an in vitro diagnostic device for detecting the Zika virus. To view the notice, click here.
FDA Policy/General
Federal Register Notice: FDA is seeking information and comments about how it plans to administer generic drug program fees beginning in fiscal year 2018 (10/1). Under the user fee program, a fee will be assessed under a three tier system based on application holders. To view the notice, click
Drugs
FDA has accepted for review an Adamas Pharmaceuticals NDA for ADS-5102 (amantadine hydrochloride) extended-release capsules for treating levodopa-induced dyskinesia in patients with Parkinson’s disease. The submission has been given a user fee review target date of 8/24. “Over time, 90% of patients on levodopa therapy
Devices
FDA has identified cybersecurity vulnerabilities with St. Jude Medical’s implantable cardiac devices and its Merlin@home Transmitter. If exploited, the vulnerability could allow an unauthorized user to remotely access a patient’s radio frequency (RF)-enabled implanted cardiac device by altering the Merlin@home Transmitter, an agency safety alert
Devices
FDA has cleared an Arterys 510(k) for its Arterys Cardio DL, a device the company says provides automated, editable ventricle segmentations based on conventional cardiac MRI images that are as accurate as segmentations performed manually by experienced physicians. It is “vendor agnostic and was developed using data from several
FDA Policy/General
While FDA’s consolidated campus in White Oak, MD has offered more collaboration opportunities and efficiencies such as shared laboratories, the campus and its use has grown rapidly and remains a high-risk security concern, according to a new Government Accountability Office report. “(D)ue to concerns about managing traffic
FDA Policy/General
DEVICES Surgical Tools for Urogynecologic Mesh Reclassified Federal Register Final Order: FDA has reclassified surgical instrumentation for use with urogynecologic surgical mesh from Class 1 (general controls) exempt from premarket notification to Class 2 (special controls) subject to premarket notification, and identifying them as ‘‘specialized surgical instrumentation for use with
Drugs
FDA is seeking information and comments (see FDA notice) about how it plans to administer generic drug program fees beginning in fiscal year 2018 (10/1). Under the user fee program, a fee will be assessed under a three tier system based on application holders: * Large (companies with 20 or
Drugs
FDA has extended by three months the user fee review date for a Roche BLA for Ocrevus (ocrelizumab), indicated for treating patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis. The new target date (3/28) will allow the agency to review a Roche submission on
Drugs
FDA has lifted a full clinical hold on CTI BioPharma’s pacritinib for treating myelofibrosis. The hold was ordered 2/2016 due to excess mortality and other adverse events in pacritinib-treated patients compared to the control arm in the PERSIST-1 trial. CTI submitted a complete response submission (see