Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement

Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement Committee Meeting September 10, 2013, from 8 a.m. to 3 p.m. The committee will discuss the new molecular entity (NME) new drug application (NDA) 203975 for umeclidinium and vilanterol powder for inhalation (proposed tradename Anoro Ellipta), sponsored by Glaxo Group (d/b/a/ GSK) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Cardiovascular and Renal Drugs AdComm

Cardiovascular and Renal Drugs AdComm Committee Meeting August 5th, 2013, 2013, from 8 a.m. to 5:30 p.m.4 On August 5, 2013, the committee will discuss new drug application (NDA) 204441, tolvaptan tablets, submitted by Otsuka Pharmaceutical Company, Ltd., for the proposed indication of slowing kidney disease in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (autosomal dominant polycystic kidney disease is a genetic disease that affects the kidney and can lead to kidney failure).

Cardiovascular and Renal Drugs Advisory Committee Meeting

Cardiovascular and Renal Drugs Advisory Committee Meeting Committee Meeting August 5th, 2013, 2013, from 8 a.m. to 5:30 p.m. On August 5, 2013, the committee will discuss new drug application (NDA) 204441, tolvaptan tablets, submitted by Otsuka Pharmaceutical Company, Ltd., for the proposed indication of slowing kidney disease in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (autosomal dominant polycystic kidney disease is a genetic disease that affects the kidney and can lead to kidney failure). FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA''''s Web site after the meeting.

Tobacco Product Analysis - A Scientific Workshop - July 2013

Tobacco Product Analysis - A Scientific Workshop - July 2013 Committee Meeting July 31, 2013 from 8:30 a.m. to 4:30 p.m. ET (Day 2 of 2) Agenda:The purpose of this workshop is to discuss and obtain input on the chemical analysis of tobacco products. Tobacco product analysis experts from academia, industry, government, and contract testing laboratories will share information on understanding the testing of cigarette smoke and tobacco filler from cigarettes, roll-your-own (RYO) tobacco, and smokeless tobacco products for tar, nicotine, and carbon monoxide (TNCO), tobacco-specific nitrosamines (TSNAs), and polycyclic aromatic hydrocarbons (PAHs). FDA will invite speakers to address specific scientific and technical matters related to TNCO in cigarette smoke TSNAs (total TSNAs, NNN, and NNK) in cigarette smoke and tobacco filler (cigarette, RYO, and smokeless) PAHs (benzo[a]pyrene, naphthalene, chrysene, benz[j]anceanthrylene, benzo[a]anthracene, benzo[b]fluoroanthene, benzo[k]fluoroanthene, benzo[c]phenanthrene, cyclopenta[cd]pyrene, dibenz[a,h]anthracene, dibenzo[a,e]pyrene, dibenzo[a,h]pyrene, dibenzo[a,i]pyrene, dibenzo[a,l]pyrene, indeno[1,2,3-cd]pyrene, and 5-methylchrysene) in cigarette smoke and tobacco filler (cigarette, RYO, and smokeless) General method testing for TNCO, TSNAs, and PAHs in tobacco filler (cigarette, RYO, and smokeless) and cigarette smoke Validation or method performance for TNCO, TSNAs, and PAHs in tobacco filler (cigarette, RYO, and smokeless) and cigarette smoke

Tobacco Product Analysis - A Scientific Workshop - July 2013

Tobacco Product Analysis - A Scientific Workshop - July 2013 Committee Meeting July 30, 2013 from 8:30 a.m. to 5:30 p.m. ET (Day 1 of 2) Agenda:The purpose of this workshop is to discuss and obtain input on the chemical analysis of tobacco products. Tobacco product analysis experts from academia, industry, government, and contract testing laboratories will share information on understanding the testing of cigarette smoke and tobacco filler from cigarettes, roll-your-own (RYO) tobacco, and smokeless tobacco products for tar, nicotine, and carbon monoxide (TNCO), tobacco-specific nitrosamines (TSNAs), and polycyclic aromatic hydrocarbons (PAHs). FDA will invite speakers to address specific scientific and technical matters related to TNCO in cigarette smoke TSNAs (total TSNAs, NNN, and NNK) in cigarette smoke and tobacco filler (cigarette, RYO, and smokeless) PAHs (benzo[a]pyrene, naphthalene, chrysene, benz[j]anceanthrylene, benzo[a]anthracene, benzo[b]fluoroanthene, benzo[k]fluoroanthene, benzo[c]phenanthrene, cyclopenta[cd]pyrene, dibenz[a,h]anthracene, dibenzo[a,e]pyrene, dibenzo[a,h]pyrene, dibenzo[a,i]pyrene, dibenzo[a,l]pyrene, indeno[1,2,3-cd]pyrene, and 5-methylchrysene) in cigarette smoke and tobacco filler (cigarette, RYO, and smokeless) General method testing for TNCO, TSNAs, and PAHs in tobacco filler (cigarette, RYO, and smokeless) and cigarette smoke Validation or method performance for TNCO, TSNAs, and PAHs in tobacco filler (cigarette, RYO, and smokeless) and cigarette smoke

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Committee Meeting July 25th, 2013 8:00 a.m. - 6:00 p.m. (Day 2 of 2) On July 25, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Kineflex Lumbar Artificial Disc sponsored by SpinalMotion. The Kineflex Lumbar Artificial Disc is a metal-on-metal (cobalt chrome molybdenum alloy) lumbar total disc replacement device. The Kineflex Lumbar Artificial Disc is indicated for reconstruction of the intervertebral disc at one level (L4-L5 or L5-S1) following single-level discectomy for lumbar degenerative disc disease (DDD) where DDD is defined as discogenic back pain with degeneration of the disc as confirmed by patient history, physical examination, and radiographic studies.

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Committee Meeting July 24th, 2013 8:00 a.m. - 6:00 p.m. (Day 1 of 2) On July 24, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Kineflex/C Cervical Artificial Disc sponsored by SpinalMotion. The Kineflex/C is a metal-on-metal (cobalt chrome molybdenum alloy) cervical total disc replacement device. The Kineflex/C is indicated for reconstruction of the intervertebral disc at one level from C3-C7 following single-level discectomy for intractable radiculopathy or myelopathy due to a single-level abnormality localized to the disc space.