[e-farmacos] FDA: guia de comunicacion de informacion de seguridad

["Madurga, Mariano" <mmadurga@agemed.es>]

Estimadas y estimados amigos,

La FDA acaba de publicar la guia sobre Comunicacion de Informacion de Seguridad de Medicamentos.

En los pasos dados por la FDA en este asunto, ha publicado este docuemnto de  17 paginas en donde se reunen los procedimientos para comunicar al publico problemas de Seguridad de Medicamentos. Tambien responde a las sugerencias de IoM (Institute of Medicine) que publicó un informe en septiembre 2006. La guia de la FDA se compendia en este indice:

TABLE OF CONTENTS

I. WHAT IS THIS GUIDANCE ABOUT? ... 1

II. WHY IS FDA ISSUING THIS GUIDANCE?... 2

III. WHAT DRUG SAFETY INFORMATION DOES FDA COMMUNICATE? ... 3

IV. HOW DOES FDA EVALUATE DRUG SAFETY INFORMATION?... 4

V. WHEN DOES FDA COMMUNICATE EMERGING DRUG SAFETY INFORMATION?... 5

VI. HOW DOES FDA COMMUNICATE IMPORTANT DRUG SAFETY INFORMATION?... 6

A. Labeling (including patient package inserts and Medication Guides) ...7

B. Public Health Advisories ... 8

C. Patient Information Sheets... 8

D. Healthcare Professional Sheets... 9

E. Alerts on Patient Information and Healthcare Professional Sheets ... 9

F. Other Methods of Communication.... 10

VII. WHERE CAN I FIND FDA'S DRUG SAFETY INFORMATION?... 10

VIII. HOW WILL FDA HANDLE CONFIDENTIAL INFORMATION? ... 11

IX. HOW WILL DRUG SAFETY INFORMATION BE UPDATED? ... 11

X. WHAT INTERACTIONS WILL FDA HAVE WITH SPONSORS BEFORE COMMUNICATING EMERGING DRUG SAFETY INFORMATION TO THE PUBLIC? ... 13

XI. HOW WILL THE COMMUNICATION OF DRUG SAFETY INFORMATION AFFECT THE PROMOTION OF PRESCRIPTION DRUGS?... 13

El documento Guia en:
http://www.fda.gov/cder/guidance/7477fnl.pdf <http://www.fda.gov/cder/guidance/7477fnl.pdf> 
 
La nota de prensa informando del asunto (Immediate Release, March 2, 2007) en:
 
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01577.html <http://www.fda.gov/bbs/topics/NEWS/2007/NEW01577.html> 
 
Un abrazo,

Mariano Madurga
AEMPS, Div FEpi y FV
mmadurga@agemed.es