Overviews and analysis of the U.S. FDA′s new approvals in the 2016 second half year / 国际药学研究杂志

In the second half of 2016,the U.S. Food and Drug Administration(FDA)approved 7 new molecular entities and 3 new Biologic License Application(BLA), the lowest number in recent years. According to the prescription information for profes-sionals,this article introduced the description,mechanism of action and clinical studies and briefly describes the boxed warning,indi-cations and usage,dosage and administration,dosage form and strength,contraindications,warning and precautions,adverse reac-tions,drug interaction and the use in the special population. In addition,the first and critical events in the history of new drug develop-ment and reaserch were emphasized.

New drugs approved by the U.S. FDA(2007-2016):a review / 国际药学研究杂志

The introductions of the new drugs approved by the U.S. FDA have been published in the“Journal of International Pharmaceutical Research”for ten years. However,new problems might emerge with the increasing clinical practice and the cumulative number of patients being treated,such as the indications and purposes change,supplement of the modified efficacy,clinical data and the important new indications,constant improvement of the dosage,form and mode of administration,and the emergence of new,seri?ous and even fatal adverse reactions urge the supplements of contraindications,warnings and precautions,or even the black box warn?ings. In brief,6 entries of the introductions all may be modified,supplemented or canceled. More importantly,ten years of general analyses also find some prominent events,such as the amount of new molecular entity(NME)and new biological products come to an obvious peak in 2015. With regard to this,this paper reviewed the prominent historical events happened in the ten years in order to provide guidance and reference for new drug research and development.

Overviews and analysis of the U.S. FDA′s new approvals in the 2015 second half year / 国际药学研究杂志

In the second half year of 2015,the U.S. Food and Drug Administration(FDA)approved 20 new molecular enti?ties single or compounds and 15 biologics license applications,a total of 35 which record number of approved innovative drugs. Ac?cording to the prescription information for professionals,this article briefly describes the description,mechanism of action and clinical studies,the box warning,indications and usage,dosage and administration,dosage form and strength,contraindications,warning and precautions,adverse reactions,drug interaction and use in special population of these new drugs. In addition,the first and criti?cal events in the history of new drug development and reaserch are emphasized.

Overviews and analysis of the U.S. FDA′s new approvals in the first half year of 2016 / 国际药学研究杂志

In the first half year of 2016,the U.S. food and drug administration(FDA)approved 9 new molecular entities and 8 new biologic license applications. According to the prescription information for professionals,this article introduces the description, mechanism of action and clinical studies;briefly describes the box warning,indications and usage,dosage and administration,dos?age form and strength,contraindications,warning and precautions,adverse reactions,drug interaction and use in special population of these new drugs. In addition,the first and critical events in the history of new drug development and reaserch are emphasized.

New drugs approved by the U.S. FDA (2007-2016): A review / 国际药学研究杂志

The introductions of the new drugs approved by the U.S. FDA have been published in the“ Journal of International Pharmaceutical Research ”for ten years. However, new problems might emerge with the increasing clinical practice and the cumulative number of patients being treated, such as the indications and purposes change, supplement of the modified efficacy, clinical data and the important new indications, constant improvement of the dosage, form and mode of administration, and the emergence of new, serious and even fatal adverse reactions urge the supplements of contraindications, warnings and precautions, or even the black box warnings. In brief, 6 entries of the introductions all may be modified, supplemented or canceled. More importantly, ten years of general analyses also find some prominent events, such as the amount of new molecular entity (NME)and new biological products come to an obvious peak in 2015. With regard to this, this paper reviewed the prominent historical events happened in the ten years in order to provide guidance and reference for new drug research and development.

Overviews and analysis of the U.S. FDA’ s new approvals in the first half year of 2016 / 国际药学研究杂志

In the first half year of 2016, the U.S. food and drug administration (FDA) approved 9 new molecular entities and 8 new biologic license applications. According to the prescription information for professionals, this article introduces the description, mechanism of action and clinical studies; briefly describes the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the first and critical events in the history of new drug development and reaserch are emphasized.

Overviews and analysis of the U.S. FDA′s new approvals in the 2015 second half year / 国际药学研究杂志

In the second half year of 2015, the U.S. Food and Drug Administration(FDA)approved 20 new molecular enti-ties single or compounds and 15 biologics license applications, a total of 35 which record number of approved innovative drugs. Ac-cording to the prescription information for professionals, this article briefly describes the description, mechanism of action and clinical studies, the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the first and criti-cal events in the history of new drug development and reaserch are emphasized.

Overviews and analysis of the U.S. FDA′s new approvals in first half year of 2015 / 国际药学研究杂志

In the first half year of 2015, the U.S. Food and Drug Administration(FDA) approved 11 new molecular entities and 5 new biologic license applications. According to the prescription information for professionals, this article introduces the description, mechanism of action and clinical studies; briefly describes the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the first and critical events in the history of new drug reaserch and development are emphasized.

Overview and analysis of the U.S. FDA′s new approvals in the second half year of 2014 / 国际药学研究杂志

In the second half year of 2014, the U.S. Food and Drug Administration (FDA) approved 72 new drugs, including 18 new molecular entities (NME) and 10 new biologic license application. According to the prescription information for professionals, this article introduces the description, mechanism of action and clinical studies; briefly describes the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the first and critical events in the history of new drug development and reaserch are emphasized.

Overviews and analysis of the U.S. FDA’s new approvals in first half year of 2015 / 国际药学研究杂志

In the first half year of 2015, the U.S. Food and Drug Administration (FDA) approved 11 new molecular entities and 5 new biologic license applications. According to the prescription information for professionals, this article introduces the description, mechanism of action and clinical studies; briefly describes the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the first and critical events in the history of new drug reaserch and development are emphasized.

Overviews and analysis of the U.S. FDA′s new approvals in 2014 first half year / 国际药学研究杂志

In the first half of 2014, the U.S. Food and Drug Administration (FDA) approved 46 new drugs, including 10 new molecular entities and 10 new biologic license applications. According to the prescription information for professionals, this article introduces the description, mechanism of action and clinical studies, briefly describs the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the “first events” in the history of new drug research, development and approval are also discussed.

Overviews and analysis of the U.S. FDA's new approvals in 2014 first half year / 国际药学研究杂志

In the first half of 2014, the U.S. Food and Drug Administration (FDA) approved 46 new drugs, including 10 new molecular entities and 10 new biologic license applications. According to the prescription information for professionals, this article introduces the description, mechanism of action and clinical studies, briefly describs the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the “first events” in the history of new drug research, development and approval are also discussed.