The US FDA has published guidance for the pharma industry on reference listed drug standards for ANDA (abbreviated new drug application) submissions. The guidance is intended to provide information to potential applicants on how to identify a reference listed drug (RLD), reference standard, and the basis of submission for an ANDA submission.
Antibiotic resistance is the result of environmental and behavioral causes. Indiscriminate antibiotic prescribing and lax enforcement laws are the main causes of antimicrobial resistance. This may be due to reckless use of antibiotics in hospitals as well as in private practice outside the easy availability of prescription drugs in the country.
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