New Draft Guidance on Maximal Usage Trials for OTC Drugs

On May 22, 2018, the US Food and Drug Administration (FDA) issued draft guidance for drug makers on maximal usage trials for the purpose of adding a topical active ingredient to an over-the-counter (OTC) drug monograph. A maximal usage trial is a pharmacokinetic (PK)...

How will Brexit change the UK and EU Biotech landscape?

As the “Brexit” deadline nears, there are several unknown questions as to how the separation will change and effect the landscape of pharmaceutical industries across Europe and possibly even the United States. The United Kingdom (UK) will not exit the European Union...