FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for IDEV Technologies’ Supera Peripheral Stent System is 1,894 days for extending a patent which claims the medical device. The system is indicated to improve luminal diameter in treating patients with symptomatic de novo or restenotic native lesions or
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Glaxo’s Breo Ellipta is 1,980 days for extending a patent which claims the human drug product. Breo Ellipta (vilanterol trifenate; fluticasone furoate) is indicated for long-term, once-daily maintenance treatment of airflow obstruction and for reducing
FDA Policy/General
DEVICES Clear Guide Medical has received 510(k) clearance from FDA to market its innovative CT-Ultrasound fusion and image guidance system, the Clear Guide SCENERGY. It will help interventional radiologists and surgeons perform minimally-invasive biopsies and other diagnostic and therapeutic procedures through an integrated display of fused ultrasound
FDA Policy/General
BIOLOGICS Guidance on Donor Screening to Reduce Zika Virus Federal Register Notice: FDA is making available a guidance: Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus. The document provides blood establishments that collect blood and blood components with recommendations for
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act,” has been submitted to the Office of Management and
FDA Policy/General
Federal Register Notice: FDA’s Anesthetic and Analgesic Drug Products Advisory Committee, the Drug Safety and Risk Management Advisory Committee, and the Pediatric Advisory Committee will meet 9/15-16 to discuss the appropriate development plans for establishing the safety and efficacy of prescription opioid analgesics for pediatric patients, including
Drugs
Baxter International has recalled one lot of 0.9% sodium chloride irrigation, USP, 500 mL plastic pour bottle solution after a report was received that an insect was in the solution. Such foreign material contamination “potentially could result in a series of complications dependent in which anatomic location the irrigation
Drugs
FDA has planned a 4/15 Nonprescription Drugs Advisory Committee meeting to review a Galderma Labs supplemental NDA seeking to switch the regulatory status of its acne gel Differen (adapalene) 0.1% from prescription-only to over-the-counter (OTC) availability. The proposed OTC use is for the treatment of
Drugs
A Duke-Margolis Center for Health Policy white paper outlines key challenges with current off-label dissemination policies and offers policy options for making real progress. The courts have recently rejected on First Amendment grounds several attempts to enforce certain restrictions on off-label communications, but this has led to
FDA Policy/General
Federal Register Notice: FDA is making available the summary report of public comments received during the open period from 11/4-12/4/14, on FDA activities under the Food and Drug Administration Safety and Innovation Act, Patient Participation in Medical Product Discussions. An electronic copy of the summary report
FDA Policy/General
Federal Register Notice: FDA is seeking public comment on submission of rotational plans for health warning label statements for smokeless tobacco products. Comments should be submitted by 4/19. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA seeks comments on (1) an extension of the study conducted with the original longitudinal youth cohort developed and surveyed for the outcome evaluation of FDA’s General Market Youth Tobacco Prevention Campaign, (2) the development of a second longitudinal cohort for the purpose of continuing the
FDA Policy/General
Federal Register Notice: FDA is making available a guidance for industry entitled Immunogenicity-Related Considerations for Low Molecular Weight Heparin. It discusses how applicants for low molecular weight heparin products should provide information on impurities and their potential impact on immunogenicity. To download this guidance, click here. To view this
FDA Policy/General
Federal Register Notice: FDA is making available a guidance: Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus. The document provides blood establishments that collect blood and blood components with recommendations for donor screening, donor deferral, and product management to reduce
FDA Policy/General
Federal Register Notice: FDA is making available a guidance for industry entitled Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations. It is intended to help sponsors determine the amounts and types of safety data to collect based on what is already known
FDA Policy/General
Federal Register Notice: FDA’s Pediatric Advisory Committee will meet 4/12 to discuss pediatric-focused safety reviews of 17 products, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. The meeting will be held from 8 a.m. to 5:30 p.m.
Drugs
FDA has approved an expanded use for Pfizer’s Ibrance (palbociclib) 125mg capsules — treating hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy. Approval was based on data from the
Drugs
FDA has approved UCB’s Briviact (brivaracetam) as an add-on treatment to other medications to treat partial onset seizures in epilepsy patients age 16 years and older. The NDA approval was based on data from three clinical trials involving 1,550 patients. Data showed that Briviact, taken along with
Devices
FDA says Pentax has issued updated, validated manual reprocessing instructions for the ED-3490TK Video Duodenoscope to replace those provided in the original device labeling. The agency says that it reviewed reprocessing instructions and the validation data and recommends that facilities using the devices should train staff on the them
Drugs
FDA has extended by three months its review of a Titan Pharmaceuticals and partner Braeburn Pharmaceuticals NDA for the maintenance treatment of opioid addiction. The agency has set a new review target date of 5/27. Following a Psychopharmacologic Advisory Committee meeting in January, FDA requested additional changes to the
Devices
FDA has cleared a ScandiDos 510(k) for the Delta [4] Discover, a device that independently verifies the radiation dose delivered to a patient during radiation treatment. “Until now, the concept of measuring the daily dose of radiation in real time, to ensure it accurately matches the patient treatment plan,
FDA Policy/General
Alliance for a Stronger FDA has urged Congressional appropriators to bump up FDA’s proposed FY 2017 budget request by $120 million (4%) in order for the agency to carry out its responsibilities. The request would increase FDA’s budget, not including user fees, to $2.85 billion. The Alliance