On December 6, 2013 it was announced that a new patient safety legislation would be introduced known as the “Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law)”. The law Continue reading
The introduction and acceptance of electronic submissions as the preferred submission process has been adopted at varying rates by different jurisdictions within the three ICH regions over the past several years. This move to provide a harmonized format has Continue reading
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
Canadian Government Introduces New Law to Protect Patients – 2013 Throne Speech Commitments on Mandatory Adverse Drug Reaction Reporting, Recalls and Accurate Labels Continue reading
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
On October 22, 2013 new legislation was introduced that would prevent the US Food and Drug Administration (FDA) from regulating mobile medical apps that do not meet a newly defined regulatory definition of Continue reading
Jan. 30, 2013. The generic pharmaceutical industry believes that there needs to be a low bar set for biosimilar products Continue reading