List of works - Rachel E Sherman

Accelerating development of scientific evidence for medical products within the existing US regulatory framework

scientific article

Case Study for Lean Management in the Public Sector: Improving Combination Product Review at the Food & Drug Administration

scientific article

Characteristics of Clinical Trials Registered in ClinicalTrials.gov, 2007-2010 ⬇️

scientific article published on May 2, 2012

Combination products: modernizing the regulatory paradigm

scientific article published on 12 May 2017

Developing the Nation's Biosimilars Program ⬇️

scientific article published on 01 August 2011

Expediting drug development--the FDA's new "breakthrough therapy" designation

scientific article published in November 2013

Flexibility in the FDA approach to orphan drug development

scientific article published in September 2017

Independent data monitoring committees: preparing a path for the future

scientific article

Knowing When and How to Use Medical Products: A Shared Responsibility for the FDA and CMS

scientific article published on 01 December 2016

New FDA Regulation to Improve Safety Reporting in Clinical Trials ⬇️

scientific article published on 08 June 2011

Real-World Evidence - What Is It and What Can It Tell Us?

scientific article

Regulatory requirements of the Food and Drug Administration would preclude product claims based on observational research

scientific article published on 01 October 2012

Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012.

scientific article published on January 2014

The FDA Sentinel Initiative - An Evolving National Resource

scientific article published on 01 November 2018

The Food and Drug Administration and pragmatic clinical trials of marketed medical products

scientific article

The US Food and Drug Administration's Sentinel Initiative: Expanding the horizons of medical product safety ⬇️

scientific article published on 01 January 2012

Transforming Evidence Generation to Support Health and Health Care Decisions

scientific article published in December 2016

List of works by Rachel E Sherman

Accelerating development of scientific evidence for medical products within the existing US regulatory framework

Case Study for Lean Management in the Public Sector: Improving Combination Product Review at the Food & Drug Administration

Characteristics of Clinical Trials Registered in ClinicalTrials.gov, 2007-2010 ⬇️

Combination products: modernizing the regulatory paradigm

Developing the Nation's Biosimilars Program ⬇️

Expediting drug development--the FDA's new "breakthrough therapy" designation

Flexibility in the FDA approach to orphan drug development

Independent data monitoring committees: preparing a path for the future

Knowing When and How to Use Medical Products: A Shared Responsibility for the FDA and CMS

New FDA Regulation to Improve Safety Reporting in Clinical Trials ⬇️

Real-World Evidence - What Is It and What Can It Tell Us?

Regulatory requirements of the Food and Drug Administration would preclude product claims based on observational research

Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012.

The FDA Sentinel Initiative - An Evolving National Resource

The Food and Drug Administration and pragmatic clinical trials of marketed medical products

The US Food and Drug Administration's Sentinel Initiative: Expanding the horizons of medical product safety ⬇️

Transforming Evidence Generation to Support Health and Health Care Decisions