美国FDA 指导原则 体内生物利用度生物等效性研究分析期末 英文原版.pdfVIP

FOOD AND DRUG ADMINISTRATION COMPLIANCE PROGRAM PROGRAM 7348.004 CHAPTER 48 – BIORESEARCH MONITORING SUBJECT: IMPLEMENTATION DATE: Procedures for FDA Staff: In Vivo Bioavailability/Bioequivalence 05/01/2018 Studies (Analytical) DATA REPORTING PRODUCT CODES PRODUCT/ASSIGNMENT CODES Product coding not required for 48004A BIOANALYTICAL IN-VIVO BA/BE biopharmaceutical establishments (ANDAS) 48004N BIOANALYTICAL IN-VIVO BA/BE (NDAS AND BLAS) 48004P BIOANALYTICAL PEPFAR ANDA BA/BE 48004Q BIOANALYTICAL PEPFAR NDA BA/BE 48004B BIOANALYTICAL BA/BE ­ BIOSIMILARS FIELD REPORTING REQUIREMENTS: To meet the established deadline(s) issued by the Center, notify the Center via the e-mail address identified in the assignment when Establishment Inspection Report (EIR), EIR attachments, exhibits, or any related correspondence is available in OSAR. All EIRs should be completed in accordance with Field Management Directive (FMD) No. 86, Establishment Inspection Report – Inspection Conclusions and District Decisions (/downloads/ICECI/Inspections/FieldManagementDirectives/UCM382035.pdf). When Form FDA 483, “Inspectional Observations” (483) is issued, a copy should be sent to the Center contact, and the Center’s email mailbox, generally no later than 3 business days foll