UPCOMING MEETINGS by FDA

UPCOMING MEETINGS:

1. Pulmonary-Allergy Drugs Advisory Committee Meeting
DATE: April 7, 2010
TIME: 8:00 a.m. to 5:00 p.m
LOCATION: Hilton Washington D.C./North Silver Spring, Maryland, The Ballrooms, 8727 Colesville Road, Silver Spring, Maryland
CONTACT: Kristine T. Khuc, Pharm.D.
Phone: 301-827-7001; E-mail: kristine.khuc@fda.hhs.gov
The committee will discuss new drug application (NDA 22-522), roflumilast (DAXAS), by Forest Research Institute, for the maintenance treatment of chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis in patients at risk of exacerbations (worsening symptoms).
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm202852.htm


2. FDA Public Meeting on the Prescription Drug User Fee Act (PDUFA)
DATE: April 12, 2010
TIME: 9:00 a.m. to 5:00 p.m
LOCATION: Hilton Washington DC/Rockville Hotel and Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852
CONTACT: Patrick Frey
Phone: 301-796-3844 E-mail: patrick.frey@fda.hhs.gov
The meeting will include brief presentations by FDA and a series of panels representing various stakeholder groups, such as patient advocacy groups, consumer groups, industry groups, and health professional groups. FDA will also provide an open public comment session during the meeting for individuals who may wish to comment. Written comments may also be submitted to the docket [Docket No. FDA-2010-N-0128] for FDA’s consideration. Registration to attend the meeting must be received by April 5, 2010 (Monday) and the docket will be open through May 12, 2010 (Wednesday). The Federal Register notice provides important information about meeting registration and the public participation process. It is available at http://edocket.access.gpo.gov/2010/pdf/2010-5664.pdf.


3. Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting
DATE: April 13, 2010
TIME: 8:00 a.m. to 5:00 p.m.
LOCATION: Hilton Washington D.C./Silver Spring, The Ballrooms, 8727 Colesville Road, Silver Spring, Maryland
CONTACT: Anuja Patel, M.P.H.
Phone: 301-827-7001 E-mail: anuja.patel@fda.hhs.gov
The committee will receive presentations from the Office of Generic Drugs (OGD) and discuss two bioequivalence (BE) topics relevant to generic drug approval: (1) revising the BE approaches for critical dose drugs; and (2) the use of partial area under the curve (AUC) for the evaluation of abbreviated new drug applications (ANDAs) for products with complex pharmacokinetic profiles.
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm203405.htm


4. Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting
DATE: April 14, 2010
TIME: 8:00 a.m. to 5:00 p.m.
LOCATION: Hilton Washington D.C./Silver Spring, The Ballrooms, 8727 Colesville Road, Silver Spring, Maryland
CONTACT: Anuja Patel, M.P.H.
Phone: 301-827-7001 E-mail: anuja.patel@fda.hhs.gov
The committee will: (1) receive presentations from the Office of Generic Drugs (OGD) on a proposal for revision of the bioequivalence (BE) approaches, specifically to discuss the addition of a limitation on point estimates; (2) receive presentations on an awareness topic to highlight some issues associated with product instability (failure of a marketed product to meet stability specifications through the expiration date), and the potential research needs to address those issues; and (3) receive and discuss presentations from Office of Pharmaceutical Science (OPS) on the regulatory challenges of drug-induced phospholipidosis (excessive intracellular accumulation of phospholipids, a kind of fatty molecule, due to the use of certain drugs).
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm204093.htm


5. Joint Meeting of the Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committee Meeting
DATE: April 22, 2010
TIME: 8:00 a.m. to 4:30 p.m.
LOCATION: Hilton Washington D.C./North Gaithersburg,The Ballrooms, 620 Perry Pkwy., Gaithersburg, Maryland
CONTACT: Kalyani Bhatt
Phone: 301-827-7001 E-mail: kalyani.bhatt@fda.hhs.gov
The committees will discuss new drug application (NDA) 22-451 ACUROX (oxycodone HCl and niacin) Tablets, Acura Pharmaceuticals, Inc., for the proposed indication of relief of moderate to severe pain where the use of an immediate-release, orally administered, opioid analgesic tablet is appropriate, and the results of studies evaluating the addition of niacin, added for the purpose of reducing the misuse of oxycodone.
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm205043.htm


6. Public Hearing and Request for Comments: Expanded Access to Direct-Acting Antiviral Agents for the Treatment of Chronic Hepatitis C Infection in Patients with Unmet Medical Need
DATE: April 30, 2010
TIME: 9:00 a.m. to 4:00 p.m
LOCATION: Hilton Hotel, 1750 Rockville Pike, Rockville, MD 20852
CONTACT: Susie Dill
Phone: 301-796-3437 E-mail: AccessToDAA@fda.hhs.gov
The FDA is announcing a public hearing to obtain input on the scope and implementation of potential expanded access programs with direct-acting antiviral agents (DAAs) for the treatment of chronic hepatitis C (CHC) infection in patients with unmet medical need. Submit written or electronic requests for oral presentations and comments by April 8, 2010. Written or electronic comments will be accepted after the hearing until June 25, 2010.
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm204216.htm


7. Peripheral and Central Nervous System Drugs Advisory Committee Meeting
DATE: May 6, 2010
TIME: 8:00 a.m. - 5:00 p.m.
LOCATION: The Inn and Conference Center, University of Maryland, University College (UMUC), Marriott Conference Centers, 3501 University Blvd. East Adelphi, Maryland
CONTACT: Diem-Kieu Ngo
Phone: 301-827-7001; Email: diem.ngo@fda.hhs.gov
The committee will discuss supplemental new drug application (sNDA) 22-432, H.P. ACTHAR Gel (repository corticotropin injection), 80 USP units per milliliter, Questcor Pharmaceuticals, proposed for the treatment of infantile spasms.
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm204893.htm


8. Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting
DATE: May 12, 2010
TIME: 8:00 a.m. to 5:00 p.m.
LOCATION: Hilton Washington D.C./Silver Spring, The Ballrooms, 8727 Colesville Road, Silver Spring, Maryland
CONTACT: Anuja Patel, M.P.H.
Phone: 301-827-7001; anuja.patel@fda.hhs.gov
The committees will discuss new drug application (NDA) 22-478, naproxcinod 375 milligram capsule, sponsored by NicOx S.A., a non-steroidal anti-inflammatory drug (NSAID) product indicated for the treatment of the signs and symptoms of osteoarthritis.
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm203426.htm


9. Endocrinologic and Metabolic Drugs Advisory Committee Meeting
DATE: May 27, 2010
TIME: 8:00 a.m. - 5:00 p.m.
LOCATION: The Inn and Conference Center, University of Maryland, University College (UMUC), Marriott Conference Centers
3501 University Blvd. East, Adelphi, Maryland
CONTACT: Paul Tran, R.Ph
Phone: 301-827-7001 E-mail: paul.tran@fda.hhs.gov
The committee will discuss the safety and efficacy of new drug application (NDA) 22–505, EGRIFTA (tesamorelin acetate), sterile lyophilized powder for injection, by Theratechnologies, Inc. EGRIFTA is an analogue (a chemical compound that resembles another compound in structure) of growth hormone releasing hormone (GHRH). The proposed indication (use) for EGRIFTA in this application is to induce and maintain a reduction of excess visceral abdominal fat in human immunodeficiency virus (HIV)-infected patients with lipodystrophy (a condition in which abnormal deposits of fat are seen partly as a result of using certain drugs to treat HIV disease).
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm205566.htm


10. Antiviral Drugs Advisory Committee Meeting
DATE: June 2, 2010
TIME: 8:00 a.m. - 5:00 p.m.
LOCATION: Hilton Washington DC/Silver Spring, 8727 Colesville Road, Silver Spring, Maryland
CONTACT: Paul Tran, R.Ph
Phone: 301-827-7001 E-mail: paul.tran@fda.hhs.gov
The committee will discuss biologics license application (BLA) 125283, motavizumab, MedImmune, LLC, proposing an indication for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease.
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm206846.htm