WHO Pharmaceuticals Newsletter 1998, No. 03&04
(1998; 18 pages)
Índice de contenido
Abrir esta carpeta y ver su contenidoRegulatory actions
Abrir esta carpeta y ver su contenidoDrug surveillance
Abrir esta carpeta y ver su contenidoNew developments
Ver el documentoRecent approvals
Abrir esta carpeta y ver su contenidoMedical devices
Cerrar esta carpetaGeneral information
Ver el documentoAdvertising of medicinal drugs in the media - regulations
Ver el documentoContainer and closure testing in lieu of sterility testing - draft guidance available
Ver el documentoExtended release oral dosage forms - draft guidance available
Ver el documentoHuman plasma-derived biological products or animal plasma or serum-derived products - draft guidance available
Ver el documentoIron-containing supplements and drugs - small entity compliance guidance available
Ver el documentoMedication errors - the "look-alike/sound alike" problem: name confusion
Ver el documentoMedication errors: esmolol - another fatal case
Abrir esta carpeta y ver su contenidoVeterinary medicine
 

Human plasma-derived biological products or animal plasma or serum-derived products - draft guidance available

United States of America. The Food and Drug Administration has announced the availability of a guidance for industry entitled "Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-derived Biological Products or Animal Plasma or Serum-derived Products", which is intended to assist applicants in the preparation of the content and format of these sections of a biologicals licence application for human plasma-derived products, animal plasma or serum-derived products.

Copies of the guidance may be obtained from the Office of Communication, Training and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville MD 20852-1448, USA (with one self-addressed adhesive label) or from the Internet at: http://www.fda.gov/cber/guidelines.htm.

Reference: Federal Register 63(13): 3145-6 (1998).

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