U.S. FDA advisory meetings through Nov. 16

THIS DIARY IS FILED AS THE FOOD AND DRUG ADMINISTRATION UPDATES ITS SCHEDULE. ALL ITEMS EDT/GMT UNTIL NOV. 6.

For more information on the FDA's Advisory Committee meetings, see: here (Adds Oct. 13 and Oct. 26-27 meetings of the circulatory system devices panel)

VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

DATE: Sept. 20, 1300/1700

LOCATION: National Institutes of Health (NIH), Building 29B/Conference Room C.

CONTACT: Donald Jehn or Denise Royster, 301-827-0314

The committee will meet to hear an overview of the research program in the Laboratory of Enteric and Sexually Transmitted Diseases at the FDA's Center for Biologics Evaluation and Research. The committee will discuss and make recommendations on the safety and immunogenicity of the Pneumococcal 13-valent conjugate vaccine in adults aged 50 years and older using an accelerated approval pathway.

CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE

DATE: Sept. 22-23, 0800/1200

LOCATION: Hilton Hotel, Washington DC North, 620 Perry Parkway, Gaithersburg, Md.

CONTACT: Gail Dapolito or Sheryl Clark, 301-827-0314

On Sept. 22, the committee will discuss a biologics license application for Umbilical Cord Blood from the New York Blood Center, indicated for hematologic malignancies, bone marrow failure, primary immunodeficiency diseases, beta thalassemia, Hurler syndrome, Krabbe disease, and X-linked adrenoleukodystrophy.

On Sept. 23, the committee will discuss a humanitarian device exemption from Miltenyi Biotec for the CliniMACS Selection System, which is meant for patients with acute myelogenous leukemia in first or second morphologic complete remission. The device can process allogeneic HLA-matched hematopoietic progenitor cells-apheresis from a related donor to obtain a CD34+ cell population intended for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional graft-vs-host disease (GVHD) prophylaxis.

PEDIATRIC ADVISORY COMMITTEE

DATE: Sept. 22-23, 0800/1200

LOCATION: Hilton Washington DC North, 620 Perry Pkwy, Gaithersburg, Md.

On Sept. 22, the committee will discuss pediatric-focused safety reviews for two influenza vaccines, Fluarix and Afluria, and for Abilify (aripiprazole). There will also be an update on a study jointly funded by the Agency for Healthcare Research and Quality (AHRQ) and FDA on antipsychotic use and metabolic effects in children.

On Sept. 23, the committee will discuss pediatric-focused safety reviews for Famvir (famciclovir), Levaquin (levofloxacin), Navstel (balanced salt ophthalmic solution with hypromellose, dextrose, and glutathione), Retrovir (zidovudine), Topamax (topiramate), Triesence (triamcinolone acetonide injectable suspension), Videx EC (didanosine), Ziagen (abacavir sulfate), and Zomig Nasal Spray (zolmitriptan). There will be an informational update on Kaletra (lopinavir/ritonavir) oral solution and tablets.

CIRCULATORY SYSTEM DEVICES PANEL

DATE: Oct. 13, 0800/1200

LOCATION: Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, Md.

CONTACT: James Swink, 301-443-0572

The committee will discuss, make recommendations and vote on information related to the premarket approval application for Cook Inc's Zilver-PTX drug-eluting stent. The stent is a self-expanding nitinol stent coated on its outer surface with the cytotoxic drug paclitaxel without any polymer, binder, or excipient at a dose density of 3 micrograms/square millimeter. Upon deployment, the Zilver-PTX stent expands to establish and maintain patency in the stented region. The proposed indications for use are treatment of de novo or restenotic symptomatic vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameter from 4 mm to 9 mm and total lesion lengths per patient of 280 mm.

POSTPONED

IMMUNOLOGY DEVICES PANEL

DATE: Oct. 14, 0800/1200

LOCATION: Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, Md.

CONTACT: Shanika Craig, 301-796-6639

The committee will discuss, make recommendations, and vote on a premarket approval application from Gen-Probe Inc GPRO.O for the Progensa PCA3 assay. The Progensa PCA3 assay is indicated for use in conjunction with other patient information to aid in the decision for repeat biopsy in men 50 years of age or older who have had one or more previous negative prostate biopsies and for whom a repeat biopsy would be recommended based on current standard of care. A lower PCA3 score is associated with a decreased likelihood of a positive biopsy.

Gen-Probe said the panel is now expected to meet in the first quarter of 2012.