Categories
rss rss-es rss-pt

Long-Acting Beta agonists (LABAs) and Inhaled Corticosteroids (ICS): Drug Safety Communication – Boxed Warning About Asthma-Related Death Removed

Murilo Freitas - 23:00, 19 de diciembre de 2017881
FDA review of clinical safety trials shows that treating asthma with LABAs in combination with ICS does not result in significantly more serious asthma-related side effects than treatment with ICS alone.

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm590001.htm

 
Categories
Inicio Mensajes

CONSULTA PÚBLICA: CONVOCATORIA DE COMENTARIOS SOBRE DOCUMENTOS PUBLICADOS EN EL SITIO WEB DE BIOLOGICOS DE LA OMS

Fernanda Lessa - 13:39, 19 de diciembre de 20172,362

**noticias en inglés**

A public consultation on the following documents is now open:

Based on WHO consultations with regulators, manufacturers and other experts the following documents were prepared and have been posted on the WHO biologicals web site http://www.who.int/biologicals/en/ for public comments:

DEADLINE for submission of comments: 12 FEBRUARY 2018

1. WHO biosafety risk assessment and guidelines for the production and quality control of novel human influenza candidate vaccine viruses and pandemic vaccines:  http://www.who.int/biologicals/vaccines/INFLUENZA_BIOSAFETY_GL_draft_1_1st_PC_22_Nov_2017_TZ.pdf?ua=1

2. Recommendations to assure the quality, safety and efficacy of recombinant hepatitis E vaccines http://www.who.int/biologicals/vaccines/HEP_E_VACCINES_Recommendations_draft_1_public_consultation.pdf?ua=1

 

DEADLINE for submission of comments: 23 FEBRUARY 2018

1.  WHO Questions and Answers: Similar Biotherapeutic Products : http://www.who.int/biologicals/QA_for_SBPs_HK_12_Dec_2017_(2).pdf?ua=1

 

All comments received by the published deadlines (shown above) will be considered in the preparation of documents that will be further discussed in 2018.

 
PRAIS 2.0