Showing 8 posts of 383 posts found.

EMA transparency criticised

May 11, 2010
Sales and Marketing EMA, Roaccutane, patient information

The European Medicines Agency (EMA) has been given a rap over the knuckles by the European Ombudsman for a perceived …

EMA appoints Alexis Nolte head of quality

May 7, 2010
Manufacturing and Production EMA, appointment, manufacturing and production

The European Medicines Agency has appointed Alexis Nolte to head up its Quality of Medicines Sector. He was previously principal …

CHMP in brief: Hospira’s Nivestim approved

March 22, 2010
Research and Development EMA

A round-up of decisions from the Committee for Medicinal Products for Human Use (CHMP), including its recommendation for a chewable version …

Single orphan document will simplify process for industry

March 1, 2010
Research and Development EMA, FDA, Orphan

The FDA and European Medicines Agency are to simplify the regulatory process for orphan medicines by agreeing to accept a …

Digital Pharma: New EMA website previewed

February 3, 2010
Research and Development, Sales and Marketing EMA, branding, digital pharma

The European Medicines Agency is preparing to overhaul its website to make it easier for users to get information. This …

FDA’s Deputy Commissioner for International Programs Murray Lumpkin

Transatlantic conversations

January 11, 2010
Research and Development EMA, FDA

The Pharmafocus interview: Murray Lumpkin, FDA Deputy Commissioner for International ProgramsCollaborations between the world’s leading medicines regulators have increased markedly …

EMA: Aligning regulation with the lifecycle of medicines

November 30, 2009
Research and Development EMA, EMEA, Thomas Lönngren, regulatory affairs

The European Agency for the Evaluation of Medicinal Products was set up in 1995 in London’s Docklands, an isolated eastern …

Lonngren lashes out at late warning

November 1, 2004
EMA, EMEA, Lonngren, Vioxx

 Thomas Lonngren, the head of Europe’s medicines regulator the EMEA has spoken out about Merck’s withdrawal of Vioxx, saying the …

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