Fast Track Approvals - Pharma

Relevant Publications

A Drug Discovery Perspective on FDA Expedited Development and Incentive Programs.

Issue Release: 2024

2023 in review: FDA approvals of new medicines.

Issue Release: 2024

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

Issue Release: 2024

Clinical trials and their impact on policy during COVID-19: a review.

Issue Release: 2024

Delivering COVID-19 vaccine trials at speed: the implementation of a phase IV UK multi-centre randomised controlled trial to determine safety and immunogenicity of COVID-19 vaccines co-administered with seasonal influenza vaccines (ComFluCOV).

Issue Release: 2024

Attitudes and perceptions about COVID-19 vaccination in the population with chronic HIV infection: A systematic review.

Issue Release: 2023

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

Issue Release: 2023

2022 FDA TIDES (Peptides and Oligonucleotides) Harvest.

Issue Release: 2023

Innovative Genoceuticals in Human Gene Therapy Solutions: Challenges and Safe Clinical Trials of Orphan Gene Therapy Products.

Issue Release: 2023

Identification of the ideal recruitment situation in pandemic research: learning from the RECOVERY trial in Northern England: a qualitative study.

Issue Release: 2022

2021 in review: FDA approvals of new medicines.

Issue Release: 2022

The Potential Benefit of Expedited Development and Approval Programs in Precision Medicine.

Issue Release: 2021

Practical and robust test for comparing binomial proportions in the randomized phase II setting.

Issue Release: 2021

Trends in FDA drug approvals over last 2 decades: An observational study.

Issue Release: 2020

Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017.

Issue Release: 2020

Launch Delay of New Drugs in China and Effect on Patients\' Health.

Issue Release: 2020

Coronavirus Vaccine: Light at the End of the Tunnel.

Issue Release: 2020

FDA and EMA Approvals of New Breast Cancer Drugs-A Comparative Regulatory Analysis.

Issue Release: 2020

Fighting COVID-19: Integrated Micro- and Nanosystems for Viral Infection Diagnostics.

Issue Release: 2020

FDA Approval and Regulation of Pharmaceuticals, 1983-2018.

Issue Release: 2020

Why Are Clinical Trials Important?

What is Cellular Stress?

What is an Abbreviated New Drug Application (ANDA)?

What are the Benefits of Collaborative Care Models?

What is Medication Management?

What Role Do Pharmacists Play in Patient Education?

What are Collaborative Care Models?

What are the Phases of Clinical Trials?

How Can Technology Aid in Management?

Why is Generic Competition Important?

Partnered Content Networks

Relevant Topics