WHO Pharmaceuticals Newsletter 1998, No. 03&04
(1998; 18 pages)
Table of Contents
Open this folder and view contentsRegulatory actions
Open this folder and view contentsDrug surveillance
Open this folder and view contentsNew developments
View the documentRecent approvals
Open this folder and view contentsMedical devices
Close this folderGeneral information
View the documentAdvertising of medicinal drugs in the media - regulations
View the documentContainer and closure testing in lieu of sterility testing - draft guidance available
View the documentExtended release oral dosage forms - draft guidance available
View the documentHuman plasma-derived biological products or animal plasma or serum-derived products - draft guidance available
View the documentIron-containing supplements and drugs - small entity compliance guidance available
View the documentMedication errors - the "look-alike/sound alike" problem: name confusion
View the documentMedication errors: esmolol - another fatal case
Open this folder and view contentsVeterinary 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Human plasma-derived biological products or animal plasma or serum-derived products - draft guidance available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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