Search results: Sage Journals

Restricted accessResearch articleFirst published September, 2017

Analysis of Review Times for Recent 505(b)(2) Applications

Sharon Sakai, Joseph A. DiMasi, Kenneth A. Getz

Therapeutic Innovation & Regulatory Science

Restricted accessOtherFirst published April, 2002

505(b)(2) Applications: History,Science,and Experience *

Gordon Johnston, Roger L. Williams

Therapeutic Innovation & Regulatory Science

Restricted accessOtherFirst published May, 2007

The 505(b)(2) New Drug Application

J. Christopher Prue, Arthur J. Mayorga

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published January, 2011

How suitable are the suitability petition and 505(b)(2)?

Nirav Chokshi, Bhaumik Modi

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Restricted accessReview articleFirst published February, 2019

Formulary Considerations for Insulins Approved Through the 505(b)(2) “Follow-on” Pathway

Jack T. Rasmussen, Heather J. Ipema

Annals of Pharmacotherapy

Restricted accessResearch articleFirst published December, 2021

505(b) (2) - A smart pathway to differentiate from competitive,low margin environment of generics

Pooja Rathee, Swagat Tripathy, Sahil Khatter [...]

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Restricted accessResearch articleFirst published March, 2006

Intermediate-Term Results of 505 Consecutive Minithoracotomy Mitral Valve Procedures

Jeffrey S. Martin, R. Duane Davis, Donald D. Glower

Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery

Restricted accessResearch articleFirst published August, 1978

Survival,Weight,and Lung Changes in Rats after Longterm Oxygen Breathing at 360 Torr and 505 Torr

William N Bernhard, Roland D Paegle, Walter W Pickut [...]

Respiratory Care

Restricted accessResearch articleFirst published March, 2006

Intermediate-Term Results of 505 Consecutive Minithoracotomy Mitral Valve Procedures

Jeffrey S. Martin, R. Duane Davis, Donald D. Glower

Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery

Open accessResearch articleFirst published 2019

Review of Drugs Approved via the 505(b)(2) Pathway: Uncovering Drug Development Trends and Regulatory Requirements

Ingrid Freije, Stéphane Lamouche, Mario Tanguay

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published September, 2017

Analysis of Review Times for Recent 505(b)(2) Applications

Sharon Sakai, Joseph A. DiMasi, Kenneth A. Getz

Therapeutic Innovation & Regulatory Science

Restricted accessOtherFirst published April, 2002

505(b)(2) Applications: History,Science,and Experience *

Gordon Johnston, Roger L. Williams

Therapeutic Innovation & Regulatory Science

Restricted accessOtherFirst published May, 2007

The 505(b)(2) New Drug Application

J. Christopher Prue, Arthur J. Mayorga

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published January, 2011

How suitable are the suitability petition and 505(b)(2)?

Nirav Chokshi, Bhaumik Modi

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Restricted accessReview articleFirst published February, 2019

Formulary Considerations for Insulins Approved Through the 505(b)(2) “Follow-on” Pathway

Jack T. Rasmussen, Heather J. Ipema

Annals of Pharmacotherapy

Restricted accessResearch articleFirst published December, 2021

505(b) (2) - A smart pathway to differentiate from competitive,low margin environment of generics

Pooja Rathee, Swagat Tripathy, Sahil Khatter [...]

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Restricted accessResearch articleFirst published March, 2006

Intermediate-Term Results of 505 Consecutive Minithoracotomy Mitral Valve Procedures

Jeffrey S. Martin, R. Duane Davis, Donald D. Glower

Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery

Restricted accessResearch articleFirst published August, 1978

Survival,Weight,and Lung Changes in Rats after Longterm Oxygen Breathing at 360 Torr and 505 Torr

William N Bernhard, Roland D Paegle, Walter W Pickut [...]

Respiratory Care

Restricted accessResearch articleFirst published March, 2006

Intermediate-Term Results of 505 Consecutive Minithoracotomy Mitral Valve Procedures

Jeffrey S. Martin, R. Duane Davis, Donald D. Glower

Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery

Open accessResearch articleFirst published 2019

Review of Drugs Approved via the 505(b)(2) Pathway: Uncovering Drug Development Trends and Regulatory Requirements

Ingrid Freije, Stéphane Lamouche, Mario Tanguay

Therapeutic Innovation & Regulatory Science