Drugs
FDA has denied an Amedra Pharmaceuticals petition asking the agency not to approve any ANDA referencing Albenza (albendazole) unless it meets specific criteria listed in the petition. The petition objected to a draft guidance that instructed ANDA applicants to measure both albendazole and its active metabolite, albendazole sulfoxide and recommended
Drugs
The Senate Committee on Homeland Security and Governmental Affairs has asked FDA to explain why it has not finalized a 2/2015 draft guidance to streamline drug expanded-access requests to allow patients access to investigational therapies outside of a clinical trial. In a 2/18 letter to the agency,
Devices
FDA’s Orthopedic and Rehabilitation Devices Panel has voted 7 to 4 not to recommend approval of a Medtronic PMA for the DIAM Spinal Stabilization System for use in skeletally mature patients that have moderate low back pain (with or without radicular pain) with current episode lasting less than one
FDA Policy/General
Federal Register Notice: FDA is seeking public comment on the information collection associated with the guidance Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims, which is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension. Comments should be submitted by 4/
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