EMA opens Amsterdam office

The European Medicines Agency has started to relocate staff from London to Amsterdam as the Brexit process comes closer

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FDA working group to oversee cannabis and derived products

A team at the US agency will explore potential pathways for dietary supplements and foods containing CBD to be lawfully ...

WuXi STA Shanghai site passes GMP inspection by Europe's MPA

The drug product manufacturing facility is located in Waigaoqiao Free Trade Zone

Disinfectant controversy: Research links overuse to MRSA

Aberdeen University study shows areas with a high concentration of cleaning agents can cause disinfectant resistance in ...

GxP: The 5 Ps of Good Practice

The FDA guidelines are complex to interpret and difficult to put into practice. Governance service provider Qualsys ...

WuXi PharmaTech subsidiaries hit regulatory and manufacturing milestone

Big moves at the pharma giant this week include WuXi Biologics becoming the first biologics company in China to be ...

EMA opens Amsterdam office

The European Medicines Agency has started to relocate staff from London to Amsterdam as the Brexit process comes closer

A strategy for wireless monitoring compliant with 21 CFR Part 11

Paul Daniel, a Vaisala regulatory expert, gives tips for best housekeeping of electronics signatures and records

Asbestos discovered in Claire's make-up, FDA reveals

The US Food and Drug Administration has found the lung cancer-causing product in three products and is calling for ...

Brexit update: UK Inspection Reports and GMP Certificates

The ECA Academy sheds light on the latest Brexit guidance documents released by the European Medicines Agency

A proactive approach to residue management

Increasing regulatory demands around residues mean life sciences cleanroom managers need to have a residue strategy in ...

A justified process for cleaning and disinfection

Is a separate and distinct cleaning step always needed before disinfection? STERIS' Walid El Azab explains the ...

Industry insight: 2018 Drug GMP warning letters

GMP consultant Barbara Unger comments on the trend seen in warning letters issued by the FDA, specifying OTC ...

Cyborg technology draws FDA attention

The US agency has drafted a preliminary guidance document for Brain-Computer Interface devices in a push to safely ...

New Canadian food safety rules: win-win for business and consumers alike

The rules focus on improving Canada's market access, prevention of contamination, and traceability for faster removal ...