Cargando…
An evaluation of drug lag for new drugs approved by the Indian regulator relative to the United States, European Union, and Japanese regulatory agencies: A 15-year analysis (2004–2018)
BACKGROUND: The approval process of every drug regulatory agency differs, and hence, the time required for the approval of a new drug varies. This results in a drug lag and India is no exception to this phenomenon. A drug lag precludes Indian patients from accessing new medicines at the same time as...
Autores principales: | Konwar, Mahanjit, Maurya, Mitesh R., Nishandar, Tushar B., Thatte, Urmila M., Gogtay, Nithya J. |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Wolters Kluwer - Medknow
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8323564/ https://www.ncbi.nlm.nih.gov/pubmed/34386381 http://dx.doi.org/10.4103/picr.PICR_99_19 |
Ejemplares similares
-
Evaluation of clinical trials done for orphan drugs versus nonorphan drugs in infectious diseasesan eleven year analysis [2010-2020]
por: Kudyar, Palvi, et al.
Publicado: (2023) -
An audit of the approval letters issued by Drugs Controller General of India to Ethics Committees in India
por: Bhide, Shruti S., et al.
Publicado: (2016) -
Investigator-initiated studies: Challenges and solutions
por: Konwar, Mahanjit, et al.
Publicado: (2018) -
The global initiative for asthma guidelines (2019): change in the recommendation for the management of mild asthma based on the SYGMA-2 trial – A critical appraisal
por: Rajan, Sujeet, et al.
Publicado: (2020) -
Current status of standardized, quality and ethical oversight of clinical research in the country: An audit of the Central Drugs Standard Control Organization (registration of ethics committees) and national accreditation board for hospital and healthcare providers (accreditation) databases
por: Nishandar, Tushar Bhimrao, et al.
Publicado: (2019)