Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee
Committee Meeting on December 14, 2011, from 8 a.m. to 6 p.m
Agenda: This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The topic to be discussed is the Center for Device and Radiological Health''s (CDRH''s) denial of a premarket approval application (PMA) for the SEDASYS computer-assisted personalized sedation system (SEDASYS) submitted by Ethicon Endo-Surgery Inc. (EES)--the sponsor for SEDASYS. The meeting will be open to the public.
Wednesday, November 30, 2011
Dermatologic and Ophthalmic Drugs Advisory Committee
Dermatologic and Ophthalmic Drugs Advisory Committee
Meeting on February 27, 2012, from 9 a.m. to 5 p.m.
Agenda: The committee will be asked to comment on the following topics related to the use of ophthalmic drug products (products intended for use in the eye): (1) Appropriate types of clinical evidence for developing anti-inflammatory drugs for the treatment of postoperative inflammation and reduction of ocular (eye) pain in patients who have undergone ocular surgery. This will include a discussion of the definition and scope of this indication as well as the types of clinical trials needed to support approval; and (2) appropriateness of marketing a single bottle of ophthalmic product for use in both eyes for postsurgical indications as it relates to the potential risk for infection. FDA’s Center for Drug Evaluation and Research would like the advisory committee to provide advice on the potential risk and approaches to mitigating that risk, including limits to fill size where appropriate
Meeting on February 27, 2012, from 9 a.m. to 5 p.m.
Agenda: The committee will be asked to comment on the following topics related to the use of ophthalmic drug products (products intended for use in the eye): (1) Appropriate types of clinical evidence for developing anti-inflammatory drugs for the treatment of postoperative inflammation and reduction of ocular (eye) pain in patients who have undergone ocular surgery. This will include a discussion of the definition and scope of this indication as well as the types of clinical trials needed to support approval; and (2) appropriateness of marketing a single bottle of ophthalmic product for use in both eyes for postsurgical indications as it relates to the potential risk for infection. FDA’s Center for Drug Evaluation and Research would like the advisory committee to provide advice on the potential risk and approaches to mitigating that risk, including limits to fill size where appropriate
Neurological Devices Panel of the Medical Devices Advisory Committee
Neurological Devices Panel of the Medical Devices Advisory Committee
Meeting on February 10, 2012, from 8 a.m. to 4:30 p.m.
Agenda: On February 10, 2012, the committee will discuss and make recommendations regarding the possible reclassification of cranial electrotherapy stimulator (CES) devices. On August 8, 2011 (76 FR 48062), FDA issued a proposed rule which, if made final, would make CES devices Class III requiring premarket approval. In response to the proposed rule, FDA received petitions under section 515(b)(2)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(b)(2)(B)) requesting a change in classification. The reclassification petitions are available for public review and comment at www.regulations.gov under docket number FDA-2011-N-0504. The committee discussion will include the existing data to support CES safety and effectiveness and whether the data are sufficient to develop special controls to support regulation of these devices under Class II.
Meeting on February 10, 2012, from 8 a.m. to 4:30 p.m.
Agenda: On February 10, 2012, the committee will discuss and make recommendations regarding the possible reclassification of cranial electrotherapy stimulator (CES) devices. On August 8, 2011 (76 FR 48062), FDA issued a proposed rule which, if made final, would make CES devices Class III requiring premarket approval. In response to the proposed rule, FDA received petitions under section 515(b)(2)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(b)(2)(B)) requesting a change in classification. The reclassification petitions are available for public review and comment at www.regulations.gov under docket number FDA-2011-N-0504. The committee discussion will include the existing data to support CES safety and effectiveness and whether the data are sufficient to develop special controls to support regulation of these devices under Class II.
Advisory Committee for Reproductive Health Drugs
Advisory Committee for Reproductive Health Drugs
Meeting on January 20, 2012, from 8 a.m. to 4:30 p.m.
Agenda: The committee will discuss the benefits and risks of new drug application 22–139, progesterone gel 8%, Columbia Laboratories, Inc., for the proposed indication of ‘‘reduction of risk of preterm birth in women with short uterine cervical length regardless of other risk factors in the mid-trimester of pregnancy.’’ The uterine cervix is the mouth of the uterus (or womb) leading into the vagina (or birth canal). The benefit/risk discussion will focus on the adequacy of the demonstration of efficacy in the U.S. population.
Meeting on January 20, 2012, from 8 a.m. to 4:30 p.m.
Agenda: The committee will discuss the benefits and risks of new drug application 22–139, progesterone gel 8%, Columbia Laboratories, Inc., for the proposed indication of ‘‘reduction of risk of preterm birth in women with short uterine cervical length regardless of other risk factors in the mid-trimester of pregnancy.’’ The uterine cervix is the mouth of the uterus (or womb) leading into the vagina (or birth canal). The benefit/risk discussion will focus on the adequacy of the demonstration of efficacy in the U.S. population.
Tobacco Products Scientific Advisory Committee
Tobacco Products Scientific Advisory Committee
Committee Meeting on January 20, 2012, from 8 a.m. to 4 p.m. (Day 3 of 3)
Agenda: As part of the Tobacco Products Scientific Advisory Committee’s required report to the Secretary of Health and Human Services, the committee will continue discussing issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.
Committee Meeting on January 20, 2012, from 8 a.m. to 4 p.m. (Day 3 of 3)
Agenda: As part of the Tobacco Products Scientific Advisory Committee’s required report to the Secretary of Health and Human Services, the committee will continue discussing issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.
Tobacco Products Scientific Advisory Committee
Tobacco Products Scientific Advisory Committee
Committee Meeting on January 19, 2012, from 8 a.m. to 5 p.m. (Day 2 of 3)
Agenda: As part of the Tobacco Products Scientific Advisory Committee’s required report to the Secretary of Health and Human Services, the committee will continue discussing issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.
Committee Meeting on January 19, 2012, from 8 a.m. to 5 p.m. (Day 2 of 3)
Agenda: As part of the Tobacco Products Scientific Advisory Committee’s required report to the Secretary of Health and Human Services, the committee will continue discussing issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.
Tobacco Products Scientific Advisory Committee
Tobacco Products Scientific Advisory Committee
Committee Meeting on January 18, 2012, from 8 a.m. to 5 p.m. (Day 1 of 3)
Agenda: As part of the Tobacco Products Scientific Advisory Committee’s required report to the Secretary of Health and Human Services, the committee will continue discussing issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.
Committee Meeting on January 18, 2012, from 8 a.m. to 5 p.m. (Day 1 of 3)
Agenda: As part of the Tobacco Products Scientific Advisory Committee’s required report to the Secretary of Health and Human Services, the committee will continue discussing issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee
Committee Meeting on January 11, 2012, from 8 a.m. to 6 p.m.
Agenda: On January 11, 2012, the committee will discuss, make recommendations, and vote on information related to the premarket approval application, sponsored by Torax Medical, Inc., for the LINX Reflux Management System, a sterile, single use, surgically placed device used to treat the symptoms associated with gastroesophageal reflux disease.
Committee Meeting on January 11, 2012, from 8 a.m. to 6 p.m.
Agenda: On January 11, 2012, the committee will discuss, make recommendations, and vote on information related to the premarket approval application, sponsored by Torax Medical, Inc., for the LINX Reflux Management System, a sterile, single use, surgically placed device used to treat the symptoms associated with gastroesophageal reflux disease.
Tuesday, November 15, 2011
Advisory Committee for Reproductive Health Drugs
Advisory Committee for Reproductive Health Drugs
Meeting on January 20, 2012, from 8 a.m. to 4:30 p.m.
AGENDA DESC Agenda: The committee will discuss the benefits and risks of new drug application 22–139, progesterone gel 8%, Columbia Laboratories, Inc., for the proposed indication of ‘‘reduction of risk of preterm birth in women with short uterine cervical length regardless of other risk factors in the mid-trimester of pregnancy.’’ The uterine cervix is the mouth of the uterus (or womb) leading into the vagina (or birth canal). The benefit/risk discussion will focus on the adequacy of the demonstration of efficacy in the U.S. population.
Meeting on January 20, 2012, from 8 a.m. to 4:30 p.m.
AGENDA DESC Agenda: The committee will discuss the benefits and risks of new drug application 22–139, progesterone gel 8%, Columbia Laboratories, Inc., for the proposed indication of ‘‘reduction of risk of preterm birth in women with short uterine cervical length regardless of other risk factors in the mid-trimester of pregnancy.’’ The uterine cervix is the mouth of the uterus (or womb) leading into the vagina (or birth canal). The benefit/risk discussion will focus on the adequacy of the demonstration of efficacy in the U.S. population.
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