Take advantage of these quick links to useful drug and medical device development resources.
FDA Center for Drug Evaluation and Research (CDER)
FDA approval of a drug means that data on the drug’s effects have been reviewed by the CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population.
Learn more about how the drug approval process takes place.
CDER Small Business Industry Assistance (SBIA)
CDER SBIA’s mission is to engage with small pharmaceutical business and industry by providing timely and accurate information on human drug development and regulation
How They Serve
CDER SBIA interacts with industry in several ways including webinars, conferences, workshops, web based tutorials and more . . .
FDA Center for Devices and Radiological Health (CDRH)
Device Advice is CDRH's premier text-based resource that explains many aspects of medical device laws, regulations, guidances, and policies, encompassing the entire product life cycle.
Drug Authorization
Learn about Health Canada drug submission applications, the drug licensing process, drug identification numbers and notices of compliance.
Medical device licensing
Access Health Canada forms and guidance documents to help you apply for a medical device licence. Also search for a licensed device using the listing database.