Regarding biotechnology/biomanufacturing/cGMPs/FDA, How is the
approval process for drugs and biologics different?
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Regarding biotechnology/biomanufacturing/cGMPs/FDA, How is theapproval process for drugs and biologics different?
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Process of approval FDA approval of a drug means that data on the drugs effects have been reviewed by CDER and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population The drug approval process takes place within a structured framework that includes Analysis of the target condition and available treatmentsFDA reviewers analyze the condition or illness for which the drug is intended and evaluate the current treatment landscape which provide the context for weighing the drugs risks and benefits For example a drug intended to treat patients with a lifethreatening disease for which no other therapy exists may be considered to have benefits that outweigh the risks even if those risks would be considered unacceptable for a condition that is not life threatening Assessment of benefits and risks from clinical dataFDA reviewers evaluate clinical
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