Real Life

FDA New Guidance on Trial Meta-Analyses

Sponsors will have to plan carefully — and show their work — if they want to use meta-analyses to prove drugs are safe, the FDA says in new draft guidance..

Sharing the Spirit

At Meditrial we like to share and celebrate...

Share Beware of Penalties!

The US Food and Drug Administration (FDA) is proposing heavy fines for pharmaceutical companies that fail to...

MDR and IVDR, What’s Up?

The rolling plan contains a list of “essential implementing acts and actions” which must be put in place...