Markets & regulatory news

Late phase clinical trials: Where the business is at, says PRA

PRA focuses on late phase services

By Natalie Morrison

PRA has expanded its operations in the Netherlands and the UK in a bid to meet what it says is soaring client demand for late phase and product registration services.

EDQM warns CEP holders of 'directory' scam

EDQM warns CEP holders of 'directory' scam

By Gareth Macdonald

The EDQM has warned manufacturers that hold Certificates of Suitability (CEP) of a new scam that asks for a fee for inclusion in a directory.

US Senate votes on FDA safety and innovation act

US Senate votes on FDA safety and innovation act

By Gareth Macdonald

The US FDA will have more powers to inspect ‘risky’ overseas pharmaceutical plants according to supporters of a bill being considered by the US senate this week. 

FDA relaxes sterility test requirement for biologics

FDA relaxes sterility test requirement for biologics

By Gareth Macdonald

The US FDA has changed its sterility testing requirements for biological products to give manufacturers greater flexibility and encourage use of ‘state-of-the-art’ analysis methods.

Chiltern sets up in Taiwan

Chiltern sets up in Taiwan

By Natalie Morrison

Chiltern has set up a legal entity in Taiwan that will allow it to establish its own local clinical research operations for the first time.

USP forges closer ties with South Korean FDA

USP forges closer ties with South Korean FDA

By Gareth Macdonald

The United States Pharmacopoeia (USP) has agreed to work with the South Korea Food and Drug Administration (KFDA) on the quality of medicines under an MOU signed this week.

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