Immunology Devices Panel of the Medical Devices Advisory Committee

Immunology Devices Panel of the Medical Devices Advisory Committee
Meeting on October 14, 2011, from 8 a.m. to 6 p.m.

Agenda: On October 14, 2011, the committee will discuss, make recommendations, and vote on a premarket approval application for the Progensa PCA3 assay sponsored by Gen-Probe, Inc. 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, before consideration of PCA3 assay results. A lower PCA3 score is associated with a decreased likelihood of a positive biopsy.

The Development and Evaluation of Next-Generation Smallpox Vaccines

The Development and Evaluation of Next-Generation Smallpox Vaccines
Meeting on September 16, 2011, from 8 a.m. to 5:30 p.m.

The public workshop will: (1) Discuss regulatory challenges and approaches related to the licensure of next generation smallpox vaccines; (2) discuss the strengths and weaknesses of various animal models relative to their ability to mimic human disease that can be used to predict the effectiveness of humans; (3) discuss the most appropriate methods to bridge immunogenicity of next-generation smallpox vaccines to licensed smallpox vaccines in clinical trials; and (4) discuss viable methods of extrapolating clinical efficacy of next-generation smallpox vaccines from immunogenicity and efficacy data from relevant animal models.

Pediatric Advisory Committee

Pediatric Advisory Committee
Meeting on September 23, 2011, from 8 a.m. to 5:30 p.m. (Day 2 of 2)

Agenda: On Friday, September 23, 2011, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for Akten (lidocaine hydrochloride), 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.

Pediatric Advisory Committee

Pediatric Advisory Committee
Meeting on September 22, 2011, from 2 p.m. to 6:30 p.m (Day 1 of 2)

Agenda: On Thursday, September 22, 2011, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act (Pub. L. 108-155), for Fluarix (influenza virus vaccine), Afluria (influenza virus vaccine), and 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.