By referring to the laws and regulations of the United States, FDA guidance documents and implementation guidelines, related news, domestic and foreign literature, we analyzed more deeply the background, content system, social disputes caused by the Right to Try Act and its important breakthroughs of the existing expanded access in this paper, so as to provide reference for the system innovation in China. Although the Right to Try Act emphasizes deregulation, simplification of procedures and relative risk control, it also emphasizes the widening of critically ill patients' right of free choice. Therefore, it is required that the introduction and construction of relevant system norms be comprehensively measured and prudently promoted in Chinese context.

Chinese Medicinal Materials Information Traceability System is an important measure for quality management of Chinese medicinal materials, and the design of the system should be strengthened. Combining with the key factors affecting the quality of Chinese medicinal materials, this paper proposes that the construction of Information Traceability System of Chinese medicinal materials should meet the quality traceability requirements of Chinese medicinal materials and embody the key factors affecting the quality of Chinese medicinal materials, which will provide reference for the design and implementation of Chinese Medicinal Materials Information Traceability System.

Lanthanum carbonate chewable tablets were approved as a phosphate binder indicated to reduce serum phosphate in patients with end stage renal disease by the US FDA in the year of 2004. Lanthanum carbonate is a gastrointestinal (GI) tract locally acting drug. The oral absorption of lanthanum carbonate is very low, so the conventional in vivo bioequivalence study with a pharmacokinetic (PK) endpoint is not feasible. The FDA recommended in vitro dissolution testing and phosphate binding studies to demonstrate bioequivalence of lanthanum carbonate preparations. Based on the literatures and guidance issued by FDA, this article discussed the in vitro phosphate binding research of lanthanum carbonate chewable tablets from the aspects of methodology, experimental design and data analysis, hoping to provide references for the development of the generic drugs.

Hollow microneedles are similar to micron-sized needles, and have the dual characteristics of injection administration and transdermal drug delivery. Hollow microneedles as a new type of transdermal drug delivery method, have shown great potential in the delivery of biological macromolecular drugs such as vaccines and insulin in recent years. Based on domestic and foreign research reports in recent years, we reviewed the penetration mechanisms, commonly used preparation materials and processes, and its application in drug delivery systems, in order to provide references for the research and development of hollow microneedles.

Microspheres have been the most commonly used embolic agents in clinical embolotherapy. However, most of the embolic microspheres used currently cannot be visualized under routine clinical imaging equipments, such as computed tomography (CT) or magnetic resonance imaging (MRI). Thus, the position and distribution of the microspheres cannot be monitored timely and accurately. In order to improve the efficacy and safety of embolization, a variety of MRI-visible embolic microspheres have been developed in recent years, but no related review has been found. Here, we summarized the MRI “visualized” embolized microspheres reported in literatures for their design, preparation and evaluation so as to provide a useful reference for the further research and development of such microspheres.

The ideal tumor targeting drug delivery system should be highly accumulated in the tumor site and release the drug quickly, while there is no leakage in the blood circulation. The accurate tumor targeting can be realized by taking advantage of the changed redox state in tumor environment and the difference of intracellular and extracellular glutathione levels, combined with the nano drug delivery system. This review introduced the principles of redox-sensitive nano drug delivery systems, redox-sensitive bond and their construction methods, also analyzed and summarized the application of different redox-sensitive nano-drug delivery systems based on liposomes, nanoparticles, nanomicelles and nanogels in tumor targeting therapy, which can provide a reference for further study of tumor targeting drug delivery.

Neonatal hypoxic ischemic brain injury (HIBD) is the main cause of neonatal mortality and neurological dysfunction in infants. Until now, the hypothermia therapy is the only effective treatment of neonatal HIBD. In recent years, with the development of new technologies, peptide drugs have attracted extensive attention due to their advantages including high selectivity, high efficiency, excellent tolerability, simple preparation process and low cost. Using neonatal HIBD models, it was revealed that many kinds of peptide drugs could enter neurocytes directly or through combining with cell penetrating peptides and play roles of brain protection through inhibiting apoptosis, reducing excitotoxicity, improving mitochondrial permeability and so on. Peptide drugs may become new therapeutic approaches of neonatal HIBD. This article reviews the latest research advances in these peptide drugs and provides a new idea for the treatment of neonatal HIBD.