Review of the organizational situation of the U.S. Drug Preparedness in terms of product stability, pharmacology, clinical findings, controlled study design, statistical analysis of the reasonableness of drug bioavailability and drug distribution, metabolism, excretion, safety, and product brochures and other evaluations. When an important new drug approval is made, a prospective basis summary is written, with each evaluator editing or writing part of the table within their authority. The United States Drug Review Organization's pharmaceutical universe assessment office, under the Office for Drug Evaluation Management, includes the organization of anticancer drugs, antivirals, diseases testing and research office, biostatistics clinical pharmacology base, engineering medicine office, material chemistry office, drug evaluation office IV, heartfelt drug trial assessment office, drug review office M, biostatistics biometrics IV, non-prescription skin and dental medicine, analgesics, anti-infective biomedical rejection contrast agents, radiopharmaceuticals anesthesia, special and hidden drugs stomach l Lu clotting drugs Health ARCH urinary drug lung drug heart, kidney medication nerve drugs Progress in Pharmaceutical Sciences 1999 23 3 FDA, which has 17 permanent Professional Advisory Boards to help the assessment department examine new drugs (including newborn items), declare the progress of the argument for new drug review, argue whether new drugs are safe and effective, and review to determine whether these drugs can be mass-produced. Advisory Committees play a significant role in reviewing special skills and program development, implementation. In recent years, the FDA has expanded the functions of the Advisory Board to accelerate the drug review process. The FDA contracts with qualified external accrediting bodies to review the backlog of New Drug Applications by evaluating the safety and efficacy of drugs based on clinical data and proving it to the FDA, while retaining the final approval right.
The organizational rules of the FDA drug review agencies include a large number of review staff from multiple areas of expertise, with multiple languages and cultural backgrounds, and competencies to perform complex drug reviews. These rules include: (1) use of non-corporate officers to prevent potential conflicts of interest; (2) employing multidisciplinary staff including medical, pharmaceutical, chemical, biological, statistical, legal and other professionals; (3) employing international experts from various cultural backgrounds; (4) punishing staff misconduct or even removing them from office; (5) ensuring scientific management and professional standards for drug review organizations, requiring university education and professional development for review staff, setting up a Training Committee to ensure professional standards, and presenting scientific management and professional standards to the Parliament of the drug review organization on academic achievements; (6) employing professional Advisory Boards to review drugs.
These organizational rules ensure the management level, professional standards, and reliability of decisions in drug review organizations, improving public confidence in the FDA’s drug review. The strengths of the FDA’s drug review organization include a sound organization and functions, hiring enough multi-disciplinary staff with high working efficiency, and using strict standards for scientific and comprehensive reviews. Its shortcomings include being subject to congressional oversight and political pressure, constantly changing top management and decision-makers leading to inadequate communication and organizational instability. The FDA has also been criticized for its scale and drug approval rate in recent years. To improve the drug review level and approval rate, thus speeding up drug research and development and better meeting market demands, the FDA recruits enough horsepower to establish a comprehensive researcher and expert team of assessors.
Since 1994, the factory began preparatory work for bulk drug exports to the United States. I participated in collecting DMF (Drug Master File) data and other specific operations to make the product pass the U.S. FDA inspection. The concrete steps are as follows: (1) preparation phase.