Guest guest Posted April 8, 2005 Report Share Posted April 8, 2005 Hi everyone! This is a letter I received a result of my letter to my congressmen and senators. It states that there is a time for public sessions. Perhaps some of you can attend? Kenda From: " CDRH ExecSec " <EXECSEC@...> Add to Address Book " 'homemadesoaper@...' " <homemadesoaper@...> Subject: Breast Implant Inquiry Date: Thu, 7 Apr 2005 11:07:24 -0400 Kenda Skaggs: Thank you for your e-mail to the Center for Devices and Radiological Health, Food and Drug Administration (FDA) concerning silicone breast implants. Please know that our goal in reviewing PMAs for these devices is to be sure that the devices are safe and effective for their intended use, and that women are adequately informed about their risks and benefits. On April 11-13, 2005 we will convene an Advisory Panel meeting at which the Panel will discuss the data from two PMAs (Inamed Corporation and Mentor Corporation) and will make a recommendation to FDA about whether or not they believe the PMAs are approvable or not approvable. We assure you that we intend to perform a thorough review of the data in the PMAs to determine whether or not they demonstrate a reasonable assurance that the implants are safe and effective for their intended use. Although a detailed agenda is not available, information about the meeting is available on the Food and Drug Administration's (FDA) website at: http://www.fda.gov/oc/advisory/accalendar/2005/cdrh12519ddd0411121305.html. There will be opportunities for public comment all day on Monday, April 11th, and for 1 hour each on Tuesday, April 12th, and Wednesday, April 13th. If you are interested in participating during the open public sessions of this Panel meeting, please refer to the website for contact information. We are presenting the PMAs to our Advisory Panel so that the Panel can provide FDA with their input on the available data. We will carefully consider the panel's deliberations as part of our review process for these PMAs. Following that process, FDA will make a final determination on whether or not the data for each PMA demonstrate a reasonable assurance of safety and effectiveness. Again, we thank you for sharing your views and for taking the time to contact us. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 8, 2005 Report Share Posted April 8, 2005 You can attend, but you had to sign up to testify about a month ago. Lynda At 06:13 PM 4/7/2005, you wrote: >Hi everyone! > >This is a letter I received a result of my letter to my congressmen and >senators. It states that there is a time for public sessions. Perhaps >some of you can attend? > >Kenda > > > >From: " CDRH ExecSec " <EXECSEC@...> Add to Address Book > " 'homemadesoaper@...' " <homemadesoaper@...> >Subject: Breast Implant Inquiry >Date: Thu, 7 Apr 2005 11:07:24 -0400 > > > >Kenda Skaggs: > >Thank you for your e-mail to the Center for Devices and Radiological >Health, Food and Drug Administration (FDA) concerning silicone breast >implants. Please know that our goal in reviewing PMAs for these devices >is to be sure that the devices are safe and effective for their intended >use, and that women are adequately informed about their risks and benefits. > >On April 11-13, 2005 we will convene an Advisory Panel meeting at which >the Panel will discuss the data from two PMAs (Inamed Corporation and >Mentor Corporation) and will make a recommendation to FDA about whether or >not they believe the PMAs are approvable or not approvable. We assure you >that we intend to perform a thorough review of the data in the PMAs to >determine whether or not they demonstrate a reasonable assurance that the >implants are safe and effective for their intended use. > > >Although a detailed agenda is not available, information about the meeting >is available on the Food and Drug Administration's (FDA) website at: ><http://www.fda.gov/oc/advisory/accalendar/2005/cdrh12519ddd0411121305.html>htt\ p://www.fda.gov/oc/advisory/accalendar/2005/cdrh12519ddd0411121305.html. >There will be opportunities for public comment all day on Monday, April >11th, and for 1 hour each on Tuesday, April 12th, and Wednesday, April >13th. If you are interested in participating during the open public >sessions of this Panel meeting, please refer to the website for contact >information. > >We are presenting the PMAs to our Advisory Panel so that the Panel can >provide FDA with their input on the available data. We will carefully >consider the panel's deliberations as part of our review process for these >PMAs. Following that process, FDA will make a final determination on >whether or not the data for each PMA demonstrate a reasonable assurance of >safety and effectiveness. > >Again, we thank you for sharing your views and for taking the time to >contact us. > > > >Opinions expressed are NOT meant to take the place of advice given by >licensed health care professionals. Consult your physician or licensed >health care professional before commencing any medical treatment. > > " Do not let either the medical authorities or the politicians mislead you. >Find out what the facts are, and make your own decisions about how to live >a happy life and how to work for a better world. " - Linus ing, >two-time Nobel Prize Winner (1954, Chemistry; 1963, Peace) > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 9, 2005 Report Share Posted April 9, 2005 Kenda, I think the schedule is already filled . . . Individual women get three minutes, group leaders get five. . . There will be three days of public hearings. .. . the women speak on Monday. Last time I was able to find a free internet broadcast on the final hours of the last day. I was hoping to find it early Monday, but I'll be at school all day Monday - playing in the mud - pottery! If anyone can figure it out, please let us know. I'll see what I can do Tuesday . . .although I have two appointments Tuesday and won't catch the whole thing. Lynda from this group is attending and others may have their testimony read by someone else. Dr. Melmed and Dr. Blais will both be there for us. Love, Rogene --- Kenda Skaggs <kdskaggs@...> wrote: > > Hi everyone! > > This is a letter I received a result of my letter to > my congressmen and > senators. It states that there is a time for public > sessions. Perhaps some > of you can attend? > > Kenda > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 20, 2005 Report Share Posted November 20, 2005 Note what the head of this FDA committee just said here: http://www.newscientist.com/channel/health/mg18825252.500 Wayne Goodman is a psychiatrist at the University of Florida and also the chair of the psychopharmacologic advisory committee of the US Food and Drug Administration. http://www.fda.gov/oc/advisory/accalendar/2005/cder12544d120205.html Psychopharmacologic Drugs Advisory Committee Center Date Time Location CDER December 2, 2005 8:00 a.m. - 5:00 p.m. Hilton The Ballrooms 620 Pkwy. Gaithersburg, MD Agenda: The committee will discuss new drug application (NDA) 21-514, proposed trade name METHYPATCH (Methylphenidate) Tdp, (Methylphenidate Transdermal System), Noven Pharmaceuticals, proposed indication for the treatment of attention deficit hyperactivity disorder (ADHD). Background material and meeting information will become available no later than one business day before the meeting (Simply scroll down to the appropriate committee heading). Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by November 18, 2005. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before November 18, 2005, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Cicely Reese at least 7 days in advance of the meeting. Contact Person: Cicely Reese, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, Rm. 1093), Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: ReeseCi@... Advisory Committee Telephone Information Line: Please call the Information Line for up-to-date information on this meeting, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512544. FDA hearings > I'm hearing something in the wind about another FDA hearing next month. > Does anyone have anything specific about what it would be for?? > > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 20, 2005 Report Share Posted November 20, 2005 Note what the head of this FDA committee just said here: http://www.newscientist.com/channel/health/mg18825252.500 Wayne Goodman is a psychiatrist at the University of Florida and also the chair of the psychopharmacologic advisory committee of the US Food and Drug Administration. http://www.fda.gov/oc/advisory/accalendar/2005/cder12544d120205.html Psychopharmacologic Drugs Advisory Committee Center Date Time Location CDER December 2, 2005 8:00 a.m. - 5:00 p.m. Hilton The Ballrooms 620 Pkwy. Gaithersburg, MD Agenda: The committee will discuss new drug application (NDA) 21-514, proposed trade name METHYPATCH (Methylphenidate) Tdp, (Methylphenidate Transdermal System), Noven Pharmaceuticals, proposed indication for the treatment of attention deficit hyperactivity disorder (ADHD). Background material and meeting information will become available no later than one business day before the meeting (Simply scroll down to the appropriate committee heading). Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by November 18, 2005. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before November 18, 2005, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Cicely Reese at least 7 days in advance of the meeting. Contact Person: Cicely Reese, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, Rm. 1093), Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: ReeseCi@... Advisory Committee Telephone Information Line: Please call the Information Line for up-to-date information on this meeting, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512544. FDA hearings > I'm hearing something in the wind about another FDA hearing next month. > Does anyone have anything specific about what it would be for?? > > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 20, 2005 Report Share Posted November 20, 2005 There is some speculation tha it may be for the adult suicide link but nothing official yet > > I'm hearing something in the wind about another FDA hearing next month. > Does anyone have anything specific about what it would be for?? > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 20, 2005 Report Share Posted November 20, 2005 There is some speculation tha it may be for the adult suicide link but nothing official yet > > I'm hearing something in the wind about another FDA hearing next month. > Does anyone have anything specific about what it would be for?? > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 20, 2005 Report Share Posted November 20, 2005 OK, It's a general drug safety hearing. Nothing yet on Adult suicidality yet. > > > > I'm hearing something in the wind about another FDA hearing next > month. > > Does anyone have anything specific about what it would be for?? > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 20, 2005 Report Share Posted November 20, 2005 OK, It's a general drug safety hearing. Nothing yet on Adult suicidality yet. > > > > I'm hearing something in the wind about another FDA hearing next > month. > > Does anyone have anything specific about what it would be for?? > > > Quote Link to comment Share on other sites More sharing options...
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