FDA releases draft guidance to outline standardized electronic study data format

When finalized, the guidance for industry “Providing Regulatory Submissions in Electronic Format – Standardized Study Data” will specify and implement electronic submission requirements for study data contained in NDAs, ANDAs, certain BLAs, and certain INDs. This guidance’s requirements will also be applied to Continue reading

FDA Recommends Tighter Restrictions on Most Popular Prescription Drug Category in the US

Access to opioid-based painkiller medications has been the topic of debate for years – some saying it should be more accessible, others arguing that it should be restricted. With the recent focus on the US opioid epidemic, individual states, industry and the FDA have been moving to increase prescriber education, create abuse resistant products and tighten regulations around opioid based drugs.

On 24 October 2013, the FDA announced it will Continue reading