What is considered Good Practice on the assessment of GMO aspects for in-vivo gene therapy products?

A recent document released by the European Commission (EC) outlines Good Practice considerations when assessing genetically modified organism (GMO) related aspects, during the conduct of clinical trials with Adeno-associated virus (AAV) vectors. Read more “What is considered Good Practice on the assessment of GMO aspects for in-vivo gene therapy products?”

FDA revises draft guidance on metered dose and dry powder inhalers

The United States (US) Food and Drug Administration (FDA) have revised draft guidance on the development and manufacture of inhalation aerosols (also known as metered dose inhalers (MDIs)) and inhalation powders (also known as dry powder inhalers (DPIs)). The guidance describes points to consider in order to ensure product quality and performance for MDIs and DPIs. It states chemistry, manufacturing, and controls (CMC) information recommended for inclusion in new drug applications (NDAs) and abbreviated new drug applications (ANDAs). Read more “FDA revises draft guidance on metered dose and dry powder inhalers”

FDA publishes draft guidance on CMC changes to a biologics license application

The US Food and Drug Administration (FDA) has published draft guidance intended to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application (BLA). Read more “FDA publishes draft guidance on CMC changes to a biologics license application”