header
  Search CBBS Website

Comments on March 2003 Federal Register proposed rules "Safety Reporting Requirements for Human Drug and Biological Products" , Docket No. 00N-1484, CDER 199665, posted March 14, 2003

A colleague in Ohio has read through the entire Department of Health and Human Services Food and Drug Administration Safety Reporting Requirements for Human Drug and Biological Products; Proposed Rule (text or PDF) and culled out portions that she believes specifically relate to Blood Banks and Transfusion Medicine, and consequently might be worth comment and discussion by the colleagues of the e-network forum. These sections appear here (PDF file).

Please submit comments to the e-Network Forum.

Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator
Printable PDF of this page


Posted: June 1, 2003

Addenda:

The e-Network Forum is supported in part by the California Blood Bank Society (CBBS) and the American Red Cross Blood Services (ARCBS) and endorses collegial discussion among blood banking and transfusion medicine professionals. However, neither the CBBS nor the ARCBS in any way endorse the specific views and opinions expressed in the forum. The forum is not intended as a substitute for medical or legal advice and the content should not be relied upon for any medical or legal purposes. Readers should make their own determinations as to: (i) what constitutes appropriate medical, technical, and administrative practices, and (ii) how best to comply with laws and regulations relevant to their questions. For the latter, they should consider consulting, as to any medical matters, a qualified physician, and, as to any legal matters, an attorney familiar with related state and federal laws. The user of the forum, by accessing same, assumes all risks arising out of such use and releases CBBS and their respective members, directors, officers and agents from and against any loss, damage, claim or liability arising out of such use of the Forum.