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The European Commission formally adopted updated regulations on good manufacturing practices for pharmaceuticals generally and for investigational drugs and clinical trials more specifically. Read More
The FDA’s draft guidance on post-approval manufacturing changes for biological products needs work to clarify how it fits with previous agency documents, according to written comments on the draft. Read More
The European Medicines Agency added new safety information for 15 excipients, including five new ingredients, in its listings of required product labeling. Read More
ViGuard Health called on the FDA to declare pyridoxamine to be a dietary supplement and no longer authorized for investigation as a new drug. Read More
The Federal Circuit upheld two Sanofi patents for its antiarrhythmic drug Multaq (dronedarone) — agreeing with Sanofi’s argument that the drug’s label, which is required to be similar for any generic versions, would ultimately direct physicians to violate the company’s patent on using Multaq to prevent abnormal heart rhythms. Read More