Fast Track And Breakthrough Designations - Pharma

Relevant Publications

Real-world evidence to support regulatory submissions: A landscape review and assessment of use cases.

Issue Release: 2024

VX-548 in the treatment of acute pain.

Issue Release: 2024

Pozelimab, a human monoclonal immunoglobulin for the treatment of CHAPLE disease.

Issue Release: 2024

Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy.

Issue Release: 2023

Clinical benefit, development, innovativeness, trials, epidemiology, and price for cancer drugs and indications with multiple special FDA designations.

Issue Release: 2023

Impact of expedited programs in the United States, as foreign regulatory factors, on clinical development time in Japan.

Issue Release: 2022

2021 in review: FDA approvals of new medicines.

Issue Release: 2022

Case Reports of DRESS Syndrome and Symptoms Consistent with DRESS Syndrome Following Treatment with Recently Marketed Monoclonal Antibodies.

Issue Release: 2019

Characteristics of non-randomised studies using comparisons with external controls submitted for regulatory approval in the USA and Europe: a systematic review.

Issue Release: 2019

Influence of Expedited Programs in the United States on Oncology Drug Development in Japan.

Issue Release: 2018

Pulmonary Arterial Hypertension: A Case Study in FDA Expedited Program Designations.

Issue Release: 2018

FDA\'s Expedited Programs and Their Impact on the Availability of New Therapies.

Issue Release: 2016

How Does the Patent System Affect Generic Competition?

What are Chronic Conditions?

What are Collaborative Care Models?

What is Transitional Care?

Why is Generic Competition Important?

What Are the Challenges in Managing Chronic Conditions?

Why is Medication Adherence Important?

Why are Collaborative Care Models Important in Pharma?

What are the Challenges in Implementing Collaborative Care Models?

What is the Future of the Pharmacy Profession?

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