Regulatory strategy and approval processes considered for PEG-drug conjugates and other nanomedicines
Therapeutic products prepared by PEG conjugation currently undergo the same regulatory scrutiny as small molecule drugs. A brief review of historical and current regulatory submission strategies is dis cussed in this chapter. In addition, some forward looking suggestions and considerations are made for nanomedicines that employ PEG and other polymers.
KeywordsApproval Process Small Molecule Drug Interferon Alpha2b Physician Desk Reference High Antiviral Activity
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