ALL QUESTIONS RELATE TO CANADA:

The most recent major amendment to Canada's Food and Drug Act occurred in 2014. A regulations defines the application and enforcement of an Act. O True O FalseA manufacturer cannot file an ANDS until the innovative reference drug patent has expired. SAP applications are received by Health Canada who coordinate with the prescriber and manufacturer. True FalseSAP applications are filed by physicians to Health Canada. True O FalseThe FDR provides 6 years + 6 months of data protection to paediatric drugs. O True O FalseAnimal studies are important for proof-of-concept during biologic development. O True O False