INFOTEHNA

MAHs are also advised to submit any Type IB variations or groupings of Type IB and Type IA variations in 2016 by 13 December 2016. The deadlines...

In a revised guidance released Friday, FDA says it is delaying the requirement for drug master files (DMF) and biological product files (BPF) to...

Beginning 5 May, pharmaceutical, biologic and generic manufacturers will have to submit to the US Food and Drug Administration’s (FDA) Center...

The International Council on Harmonisation has outlined a proposal to extend the remit of the Points to Consider (PtC) Working Group to provide...

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Wednesday released its agenda of new and revised...

US Food and Drug Administration has released a revised version of its proposal to collect quality metrics data from drugmakers in response to...

The European Medicines Agency (EMA) is advising marketing authorisation holders to submit any Type IAIN and Type IA variations for 2016 by...

FDA began implementing the recently passed 21st Century Cures Act by publishing a draft list of class II devices that will be exempt from...

The European Commission has opened for public comment a revised guideline concerning the list of excipients. The guideline’s revision includes a...

Regulators in the European Union (EU) and the United States (US) have agreed to recognize inspections of manufacturing sites for human medicines...