| |
DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE
DATE AND TIME: February 1, 8:00 a.m.
LOCATION: Hilton Washington DC/Silver Spring, Maryland Ballroom, 8727 Colesville Rd., Silver Spring, MD
CONTACT: Teresa Watkins, 301-827-7001. The committee will discuss the efficacy and safety of new drug application (NDA) 22-054, INJECTAFER (ferric carboxymaltose injection), Luitpold Pharmaceuticals Incorporated, used for the treatment of iron deficiency anemia in patients. More Information
CELLULAR, TISSUE AND GENE THERAPIES ADVISORY
COMMITTEE
DATE AND TIME: February 5, 12:00 p.m.
LOCATION: National Institutes of Health, Building 29B, Conference Room C, 9000 Rockville Pike, Bethesda, MD. This meeting will be held by teleconference. The public is welcome to attend the meeting at the specified location. A speakerphone will be provided at the specified location for public participation in the meeting, on site.
CONTACT: Gail Dapolito or Danielle Cubbage, 301-827-0314. The committee will meet in open session to hear updates of research programs in the Division of Therapeutic Proteins and the Division of Monoclonal Antibodies, Office of Biotechnology Products, Center for Drug Evaluation and Research, FDA. More Information
PSYCHOPHARMACOLOGIC DRUGS ADVISORY COMMITTEE
DATE AND TIME: February 6, 8:00 a.m.
LOCATION: Crowne Plaza Silver Spring, Kennedy Ballroom, 8777 Georgia Ave., Silver Spring, MD
CONTACT: Diem-Kieu Ngo, Center for Drug Evaluation and Research, 301-827-7001. The committee will discuss new drug application (NDA) 22- 173, ZYPREXA ADHERA (olanzapine pamoate depot) long acting intramuscular injection (210 milligrams (mg), 300 mg, and 405 mg per/ vial), Eli Lilly and Co., for the treatment of schizophrenia. A particular safety concern for discussion is the occurrence of severe somnolence in some patients who are administered this depot formulation of olanzapine. More Information
MEETING CANCELLED: PULMONARY-ALLERGY DRUGS ADVISORY COMMITTEE
DATE AND TIME: February 20, 8:00 a.m.
CONTACT: More Information
ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE
DATE AND TIME: February 27-28, 8 a.m.
LOCATION: Crowne Plaza Silver Spring, The Ballrooms, 8777 Georgia Ave., Silver Spring, MD
CONTACT: Sohail Mosaddegh, Center for Drug Evaluation and Research, 301-827-7001. On February 27, the committee will discuss new drug application (NDA) 022-110, telavancin powder for reconstitution and intravenous administration, Theravance, Inc., proposed for the treatment of complicated skin and skin structure infection. On February 28, the committee will discuss NDA 022-132, ceftobiprole medocaril (500 milligrams), lyophilized powder for reconstitution and intravenous administration, Johnson and Johnson Pharmaceutical Research and Development, LLC, proposed for the treatment of complicated skin and skin structure infection. More Information
QUALITY SYSTEM REGULATION EDUCATIONAL FORUM ON DESIGN CONTROLS
DATE AND TIME: April 4, 8:00 a.m.
LOCATION: Adam's Mark Hotel Dallas, 400 North Olive St., Dallas, TX
CONTACT: David Arvelo, FDA, 214-253-4952. The workshop is being held in response to the interest in the topics discussed from small medical device manufacturers in the Dallas District area. The goal of the workshop is to present information that will enable manufacturers and regulated industry to better comply with the Medical Device QSR. The following topics will be discussed at the workshop: (1) Planning design controls, (2) design inputs and outputs, (3) design validation and verification, (4) design transfer and change, (5) control of suppliers, (6) design history file, and (7) how design controls relate to corrective and preventive action, change control, and risk management. More Information Amendment of Notice
CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE
DATE AND TIME: April 10-11, 9:00 a.m. (8:00 on the 11th)
LOCATION: Hilton DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD
CONTACT: Gail Dapolito or Danielle Cubbage, Center for Biologics Evaluation and Research, 301-827-0314. On April 10, 2008, the committee will meet to discuss scientific considerations for safety testing for cellular therapy products derived from human embryonic stem cells. On April 11, 2008, the committee will meet to discuss updates on the following topics: (1) Research management related to the September 29, 2005, review of research programs of the Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research; (2) FDA's Somatic Cell Therapy Letter; and (3) recently released FDA guidance documents. More Information
RSS Feed for Upcoming Meetings Information [what's this?] |
 |
|
|
|
|
|
