The spelling of the word "OPS CDER" might seem confusing at first glance, but it can be explained through the International Phonetic Alphabet (IPA). "OPS" can be pronounced as /ɒps/, with the "o" sounding like the "o" in "cot" and the "ps" pronounced together as a voiceless consonant cluster. "CDER" is pronounced as /siːdiːiːˈɑr/, with both "c" and "d" making a "s" sound, and the vowels pronounced as "ee" and "ah". This unique spelling is likely an acronym or abbreviation, rather than a traditional English word.
OPS CDER stands for Operations Division of the Center for Drug Evaluation and Research. The Center for Drug Evaluation and Research (CDER) is a division of the U.S. Food and Drug Administration (FDA) responsible for evaluating the safety and efficacy of pharmaceutical drugs and ensuring their quality before they are marketed and distributed to the public. OPS CDER, also known as the Operations Division of CDER, is a specific branch within CDER that focuses on managing the daily operations and activities related to drug evaluation, approval, and regulation.
The OPS CDER division is responsible for various functions within CDER. This includes overseeing the process of drug application review, managing post-marketing surveillance and regulatory compliance, conducting inspections and audits, ensuring adherence to regulatory standards, and monitoring drug recalls and safety issues. In addition, OPS CDER collaborates with other divisions, government agencies, and stakeholders to address drug-related challenges, streamline processes, and improve regulatory practices.
OPS CDER plays a crucial role in ensuring the safety and effectiveness of pharmaceutical drugs available in the U.S. market. Through its activities, the division works towards maintaining the integrity of the drug evaluation and approval process, safeguarding public health, and promoting the development of innovative and beneficial therapies.