scholarly journals Digital Medicine: Innovative Drug-Device Combination as New Measure of Medication Adherence

2017 ◽  
Vol 33 (4) ◽  
pp. 137-139 ◽  
Author(s):  
Ximena Vallejos ◽  
Christine Wu
Keyword(s):  
Medication Adherence ◽  
Renal Transplant ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Drug Application ◽  
Innovative Drug ◽  
New Drug ◽  
Digital Medicine ◽  
New Drug Application

In September 2015, the Food and Drug Administration accepted the first digital medicine new drug application for a drug-device combination of Otsuka’s Abilify® (aripiprazole) and an ingestible sensor embedded in the tablet that digitally records ingestion. When this digital medicine is taken, it sends a signal to a patch worn by the patient. The information is recorded, time-stamped, and relayed to any Bluetooth-enabled device and, with patients’ consent, to their physicians and/or their caregivers. An encapsulation model in which a tablet is co-encapsulated with the ingestible sensor has been successfully used in the setting of renal transplant, diabetes, hypertension, and hypercholesterolemia.

scholarly journals Novos medicamentos registrados no Brasil: podem ser considerados como avanço terapêutico?

2010 ◽  
Vol 15 (suppl 3) ◽  
pp. 3403-3412 ◽  
Author(s):  
Cíntia Maria Gava ◽  
Jorge Antonio Zepeda Bermudez ◽  
Vera Lúcia Edais Pepe ◽  
André Luiz Almeida dos Reis
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Drug Application ◽  
New Drug ◽  
New Drug Application

Avanços tecnológicos no último século permitiram a descoberta de vários fármacos. Sua introdução, nem sempre com ganhos terapêuticos expressivos e não destituídos de riscos, faz do registro importante momento na avaliação de novos medicamentos. Foi analisado o registro de 49 novos medicamentos pela Agência Nacional de Vigilância Sanitária entre 2000 e 2002 e comercializados no primeiro semestre de 2003, considerando o ganho terapêutico ante os tratamentos existentes. Predominou a produção por empresas americanas (42,9%). A maioria dos medicamentos (63,3%) foi classificada como entidade molecular nova, seguindo-se as novas associações (28,6%). Possuíam registro na Food and Drug Administration 75,5% dos medicamentos, sendo possível obter a classificação de sua New Drug Application segundo o potencial terapêutico para 33 medicamentos, dos quais 57,6% foram classificados como padrão. Conclui-se que predomina o registro de medicamentos sem real vantagem terapêutica sobre os já existentes, fato também verdadeiro internacionalmente. São feitas sugestões à Anvisa de forma a estabelecer e divulgar informações quanto à inovação, eficácia e segurança dos novos medicamentos, já que são importantes para o consumidor, os profissionais de saúde e os gestores.

Information Technology & FDA Compliance in the Pharmaceutical Industry

2011 ◽  
pp. 262-273
Author(s):  
Raymond Papp
Keyword(s):  
Information Technology ◽  
Pharmaceutical Industry ◽  
Food And Drug Administration ◽  
Drug Application ◽  
Over The Counter ◽  
Electronic Submission ◽  
Current Process ◽  
New Drug ◽  
Corporate Goals ◽  
New Drug Application

Given the recent profitability of and demand for pharmaceuticals, from prescription antibiotics and analgesics like Ciproflaxin and OxyContin and mens health drugs such as Viagra and Vardenafil to over-the-counter Senokot laxatives and Betadine antiseptics, the rush to develop and market new pharmaceuticals has never been greater. The current process is complex and it often takes several years for a drug to reach the market due to the myriad of Food and Drug Administration (FDA) guidelines. Furthermore, the recent FDA guidelines mandating that all New Drug Applications (NDA) be submitted in electronic (paperless) format by the end of 2002 is a catalyst for change in the pharmaceutical industry (FDA Proposes First Requirement for Electronic Submission, 2002; New Drug Application (NDA), 2001). Bayer Pharmaceutical, like its competitors Purdue Pharma and Boots Healthcare, has begun to take steps to assure that its use of information technology will allow it to not only meet FDA guidelines, but achieve its corporate goals of improved efficiency and reduced operating costs.

Information Technology & FDA Compliance in the Pharmaceutical Industry

2011 ◽  
pp. 280-291
Author(s):  
Raymond Papp
Keyword(s):  
Information Technology ◽  
Pharmaceutical Industry ◽  
Food And Drug Administration ◽  
Drug Application ◽  
Over The Counter ◽  
Electronic Submission ◽  
Current Process ◽  
New Drug ◽  
Corporate Goals ◽  
New Drug Application

Given the recent profitability of and demand for pharmaceuticals, from prescription antibiotics and analgesics like Ciproflaxin™ and OxyContin™ and men’s health drugs such as Viagra™ and Vardenafil™ to over-the-counter Senokot™ laxatives and Betadine™ antiseptics, the rush to develop and market new pharmaceuticals has never been greater. The current process is complex and it often takes several years for a drugto reach the market due to the myriad of Food and Drug Administration (FDA) guidelines. Furthermore, the recent FDA guidelines mandating that all New Drug Applications (NDA) be submitted in electronic (paperless) format by the end of 2002is a catalyst for change in the pharmaceutical industry (FDA proposes first requirement for electronic submission, 2002; New Drug Application [NDA], 2001). Bayer Pharmaceutical, like its competitors Purdue Pharma and Boots Healthcare, has begun to take steps to assure that its use of information technology will allow it to not only meet FDA guidelines, but achieve its corporate goals of improved efficiency and reduced operating costs.

scholarly journals 2020 FDA TIDES (Peptides and Oligonucleotides) Harvest

2021 ◽  
Vol 14 (2) ◽  
pp. 145
Author(s):  
Othman Al Musaimi ◽  
Danah Al Shaer ◽  
Fernando Albericio ◽  
Beatriz de la Torre
Keyword(s):  
Adverse Effects ◽  
Global Health ◽  
Drug Administration ◽  
Mode Of Action ◽  
Chemical Structure ◽  
Food And Drug Administration ◽  
Health Crisis ◽  
New Drug ◽  
Target Mode ◽  
The Us

2020 has been an extremely difficult and challenging year as a result of the coronavirus disease 2019 (COVID-19) pandemic and one in which most efforts have been channeled into tackling the global health crisis. The US Food and Drug Administration (FDA) has approved 53 new drug entities, six of which fall in the peptides and oligonucleotides (TIDES) category. The number of authorizations for these kinds of drugs has been similar to that of previous years, thereby reflecting the consolidation of the TIDES market. Here, the TIDES approved in 2020 are analyzed in terms of chemical structure, medical target, mode of action, and adverse effects.

Utility of Bayesian Single-Arm Design in New Drug Application for Rare Cancers in Japan: A Case Study of Phase 2 Trial for Sarcoma

2018 ◽  
Vol 52 (3) ◽  
pp. 334-338 ◽  
Author(s):  
Akihiro Hirakawa ◽  
Tadaaki Nishikawa ◽  
Kan Yonemori ◽  
Taro Shibata ◽  
Kenichi Nakamura ◽  
...  
Keyword(s):  
Drug Application ◽  
Phase 2 ◽  
Rare Cancers ◽  
New Drug ◽  
Phase 2 Trial ◽  
New Drug Application
Sign in / Sign up

Export Citation Format

Share Document