Browse full definitions for every FD term in the Amicus glossary.
/ˌɛf.diːˈeɪ/
The FDA approved the new vaccine after extensive clinical trials.
The term 'FDA' is often used as a standalone abbreviation in legal and regulatory contexts related to health and safety laws.
/ˌɛfˌdiːˈeɪ əˈpruːvəl/
The company received FDA approval after extensive safety testing.
FDA approval is a key regulatory milestone ensuring that products meet safety and efficacy standards before reaching consumers.
/ˌɛfˌdiːˈeɪ ˈklɪərəns/
The company received FDA clearance for its new cardiac monitor, permitting its sale in the United States.
FDA clearance via a 510(k) pathway differs from FDA approval in that it is a less stringent authorization based on equivalence rather than extensive clinical data.
/ˌɛf di eɪ ˌrɛɡjʊˈleɪʃənz/
The company had to revise its clinical trial protocols to comply with FDA regulations.
FDA regulations are a critical subset of administrative law and must be drafted with precision to ensure compliance and effective enforcement.
