Regulatory & Safety

The serialisation stragglers: industry concern for complacency

iStock/ronstik

The US Food and Drug Administration’s (FDA) decision to delay serialisation regulations shows drug companies and contract manufacturers are still unprepared, say industry representatives.

iStock/AdrianHancu

EU to probe if drug firms' pre-submission meetings sway EMA approval decisions

iStock/jarun011

US FDA reaffirms hold on oral Proellex trials prompting Repros rethink

Tubilux Pharma SPA in Pomezia (source Google maps)

US FDA warns opthalmic supplier Tubilux about Italian plant

iStock/Rost-9D

US FDA to decide on Spark's vision loss gene therapy Luxturna in January

iStock/sal73it

Unorderly Brexit will cause UK drug shortages warn industry groups

iStock/BrianAJackson

Another regulatory hit for Ocular, US FDA rejects eye drug

iStock/filipefrazao

Label lapse: Brazil suspends ulcer drug

iStock/ibreakstock

Mallinckrodt pays $35m to settle alleged oxy reporting and production breaches

iStock/allanswart

Concerns raised about Italy and Greece as backdoors into the FMD protected meds markets

More Regulatory & Safety