FDA releases new guidance on instructions for use for biologicals

Guidelines/ | Posted 29/07/2022 comments 0
Label FDA V14b20

The US Food and Drug Administration (FDA) has released new guidance on Instructions for Use (IFU) for human prescription drugs and biological products. The guidance is an updated version of a 2019...

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Naming 3 V13J04
Nomenclature of biologicals and biocomparables in Mexico
Posted 18/03/2022

Following the articles on the management and implementation of the nomenclature of biol...

25 AA011049
COVID-19 vaccine produced in Latin America
Posted 18/03/2022

The World Health Organization (WHO) approved a COVID-19 vaccine produced in Latin Ameri...

Biosimilars approved in Colombia
Posted 11/02/2022

In Colombia, the regulatory body for the approval of biologicals is the National Food a...

Home/Non‐Biological Complex Drugs
Liposome V15L11

On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft guidance...

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