Art of Writing a Clinical Overview

2017 Ushers in New FDA Rules and Guidance

By Ann Meeker-O’Connell Found in: Article, Regulatory Affairs

As 2016 came to a close, the US FDA issued or signaled intent to issue updated regulations and final guidance that impact…

Advertising and Promotion Regulatory Affairs Conference

Omni Shoreham Hotel

EU-US Collaboration to Boost Medicine Development for Rare Diseases

Found in: Article, Rare, Orphan Diseases, Regulatory Affairs, Clinical Research

The European Medicines Agency (EMA) and the US Food & Drug Administration (FDA) have set up a new “cluster” on rare diseases to…

Medical Affairs and Scientific Communications Forum

Hilton Tucson El Conquistador Golf & Tennis Resort

When Should Foreign Sponsors Appoint Their ICR in Japan?

By Shogo Nakamori Found in: Article, Good Clinical Practices & QA, Regulatory Affairs

The proportion of multinational clinical trials that include Japan has grown from 7.4% in 2007 to 28.1% in 2013, and the Japan…

Regulatory Affairs: The IND, NDA, and Postmarketing

Westin Gaslamp Quarter, San Diego

FDA Commissioner Califf Speaks with "Global Forum"

By Alberto Grignolo, PhD, Global Forum Deputy Editor Found in: Article, PE / Quality of life / Health, Comparative Effectiveness, Clinical Research, Regulatory Affairs

After appearing in the DIA 2016 Annual Meeting panel discussion International Regulatory...

Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

Westin Gaslamp Quarter, San Diego

How Far Can Regulators Drive Patient Engagement?

Found in: Article, Clinical Research, Comparative Effectiveness, PE / Quality of life / Health, Regulatory Affairs

Patient engagement is a full-fledged global movement driven not only by patients but by agencies such as the US FDA and the UK…

Ann Meeker-O'Connell

2017 Ushers in New FDA Rules and Guidance

By Ann Meeker-O’Connell Found in: Article, Regulatory Affairs

As 2016 came to a close, the US FDA issued or signaled intent to issue updated regulations and final guidance that impact…

EU-US Collaboration to Boost Medicine Development for Rare Diseases

Found in: Article, Rare, Orphan Diseases, Regulatory Affairs, Clinical Research

The European Medicines Agency (EMA) and the US Food & Drug Administration (FDA) have set up a new “cluster” on rare diseases to…

When Should Foreign Sponsors Appoint Their ICR in Japan?

By Shogo Nakamori Found in: Article, Good Clinical Practices & QA, Regulatory Affairs

The proportion of multinational clinical trials that include Japan has grown from 7.4% in 2007 to 28.1% in 2013, and the Japan…

FDA Commissioner Califf Speaks with "Global Forum"

By Alberto Grignolo, PhD, Global Forum Deputy Editor Found in: Article, PE / Quality of life / Health, Comparative Effectiveness, Clinical Research, Regulatory Affairs

After appearing in the DIA 2016 Annual Meeting panel discussion International Regulatory...

How Far Can Regulators Drive Patient Engagement?

Found in: Article, Clinical Research, Comparative Effectiveness, PE / Quality of life / Health, Regulatory Affairs

Patient engagement is a full-fledged global movement driven not only by patients but by agencies such as the US FDA and the UK…

The Evolution of Patient Engagement at FDA

By John Whyte, MD, Director, CDER’s Professional Affairs & Stakeholder Engagement Staff Found in: Article, PE / Quality of life / Health, Regulatory Affairs

The drug approval process has traditionally relied heavily on scientific evidence for safety and efficacy. In a recent evolution…

FDA Is Reaching Out to You on Social Media!

By Ginneh D. Stowe, MS, CDER, FDA Found in: Article, PE / Quality of life / Health, Regulatory Affairs, Medical Communications

A key element of US FDA’s mission is helping the American public get the accurate, science-based medical product information they…

Breaking News: New Breakthrough Pathways

Found in: Article, Regulatory Affairs, R&D / Strategic Issues, Rare, Orphan Diseases, Clinical Research

Patient advocacy, unmet medical needs and regulatory innovations are driving accelerated review and approvals of critical…

FDA Accelerated Pathways: The New Normal

By Barry Farrimond, Jonathan Fleming and Mark Mathieu Found in: Article, Regulatory Affairs, Clinical Research, Rare, Orphan Diseases

The FDA’s accelerated pathways (APs) – including Accelerated Approval (AA), Breakthrough Therapy Designation (BTD), Fast Track…

Future Vision: Big Data in Regulatory Environment

By Richard C. Zink, PhD Found in: Regulatory Affairs, Comparative Effectiveness, Clinical Data Management, Good Clinical Practices & QA, Rare, Orphan Diseases, Article

The forward-looking DIA 2016 Annual Meeting session Envision the Future: How Big Data & Artificial Intelligence Change our…

Regulators Discuss BREXIT & Cancer Moonshot

Found in: Article, Regulatory Affairs, GMP, Public Policy / Law, Clinical Safety & Pharmacovigilance, Strategic Planning

One of the first DIA 2016 Annual Meeting DIAmond sessions, International Regulatory Convergence, Collaboration, and Cooperation…

Elevate Patient Voice to Advance Drug Development

By Ann Meeker-O'Connell, DIA Global Forum US Regional Editor Found in: Article, Regulatory Affairs, Clinical Research, Patient Engagement

The development of the US FDA’s Patient-Focused Drug Development (PFDD) initiative in 2012 heralded a new era of patient…

FDA QS Implementation for CoDx Lab-Developed Tests

By Joshua D. Levin, Kennita N. Riddick and Eunice Y. Lee Found in: Article, Regulatory Affairs, GLP, Quality Assurance, Quality Control, Devices & Diagnostics

FDA’s guidance document for in vitro companion diagnostic devices (IVD CoDx) states that, ideally, an IVD CoDx is approved at…

RbM: Hype, Paradigm Change or New Frontier?

By Dr. Peter Schiemann Found in: Article, Regulatory Affairs, Clinical Research, Good Clinical Practices & QA, Project Management

Since FDA and EMA published their guidance and reflection paper on risk-based monitoring (RbM) and oversight in clinical trials…

What IS a Combination Product?

Found in: Article, Combination Products, Regulatory Affairs

A combination product is comprised of two or more regulated components – i.e.,..

Editorial: Progress on Behalf of Children

By Stephen P. Spielberg, MD, PhD; Editor-in-Chief, DIA Publications Found in: Article, Clinical Research, Regulatory Affairs

In July 2000, our working on group on ICH E-11 completed its task of writing a document designed to harmonize...

FDA Commissioner Speaks with "Global Forum"

By Dr. Alberto Grignolo, PAREXEL; Deputy Editor, Global Forum Found in: Article, Comparative Effectiveness, Patient Engagement, Regulatory Affairs

After appearing in the DIA 2016 Annual Meeting panel discussion "International Regulatory Convergence, Collaboration and...

The Evolution of Patient Engagement at FDA

By John Whyte, MD Found in: Article, PE / Quality of life / Health, Patient Engagement, Regulatory Affairs, R&D / Strategic Issues

The drug approval process has traditionally relied heavily on scientific evidence for safety and efficacy. In a recent evolution...

FDA’s Accelerated Pathways Are The New Normal (And They Work if You Work Them)

By Barry Farrimond, Jonathan Fleming and Mark Mathieu Found in: Article, Public Policy, Health Care Compliance, Law, Public Policy / Law, Regulatory Affairs, R&D / Strategic Issues, Submissions

The FDA’s accelerated pathways (APs) – including Accelerated Approval (AA), Breakthrough Therapy Designation (BTD)...

An Overview and Analysis Regarding the Use of Adjudication Methods in EU and US Drug Approvals

By Stephanie Krumholz-Bahner, Dr rer medic, NDA Regulatory Service Switzerland GmbH, Switzerland; Mimmo Garibbo, Ethical GmbH, Switzerland; Kenneth A. Getz, MBA, Tufts University; Beat E. Widler, PhD, Widler & Schiemann Ltd, Switzerland Found in: Article, Clinical Research, Regulatory Affairs, Study Endpoints

Several regulatory guidelines recommend that assessments of endpoints supporting drug approval should be verifiable by applicants…

How the Critical Path Initiative Addresses CDER’s Regulatory Science Needs

By Mark Geanacopoulos, PhD; Ruth Barratt, PhD, DVM; CDER, Office of Translational Sciences Found in: Article, Regulatory Affairs, Statistics

Since 2008, the Critical Path Initiative has supported FDA’s program of intramural research projects in regulatory science, with…

Breakthrough Therapy Designation Bringing Innovation Swiftly to Patients

By Arpita Shah, PharmD, RPh; Regulatory Affairs, Celgene Corporation Found in: Article, Clinical Research, Public Policy / Law, Public Policy, Health Care Compliance, Law, R&D / Strategic Issues, Regulatory Affairs

In early 2012, the Breakthrough Therapy Act was introduced into the US House of Representatives and the Senate...

Clinical Data Transparency

By Janet Woodcock, MD and Anne M. Rowzee, PhD Found in: Clinical Data Management / eClinical, Public Policy / Law, Regulatory Affairs, Clinical Research, Article

It’s no surprise that DIA thought leaders have named “Clinical trial data transparency/data sharing” as the #2 trend to shape the world of medical product development in 2015.

Global Forum Special Section: The DUKE-National University of Singapore (NUS) TeamLEAD Approach to Learning

By Silke Vogel, PhD Found in: Article, Regulatory Affairs

From March 17-19, 2014, nearly 50 mid- to senior-level MRCT evaluators and regulators from 19 APEC countries gathered in Singapore to attend the Pilot Workshop of the APEC Regulatory Science Center of Excellence (COE).

Global Forum Special Section: What Happened in Singapore Should Not Stay in Singapore

By Bob Li Found in: Article, Regulatory Affairs

A pilot course over three days delivered by six faculty members was conducted at the Duke-NUS CoE for MRCT Methodology March 17-19, 2014.

Global Forum Special Section: Regulatory Collaboration in Asia Pacific Economies

By Capt. Justina A. Molzon, MS Pharm, JD Found in: Article, Regulatory Affairs

The Asia-Pacific Economic Cooperation (APEC) is a forum for Pacific Rim economies to promote economic cooperation throughout the Asia Pacific region.

Global Forum Special Section: Regulatory Collaboration: The First APEC RHSC MRCT Pilot Training Program

By Capt. Justina A. Molzon, MS Pharm, JD Found in: Article, Regulatory Affairs

The world’s first pilot training program on Multi-Regional Clinical Trials (MRCTs), endorsed by APEC (Asia-Pacific Economic Cooperation) and organized by Singapore’s Health Sciences Authority (HSA) and the Duke- NUS Graduate Medical School Singapore (Duke-NUS), was successfully concluded in Singapore this past March.

Global Forum Special Section: Q&A with Gayatri Rao, Director, OOPD

By Gayatri R. Rao, MD, JD Found in: Regulatory Affairs, Article, Clinical Research, Anti-doping, Rare, Orphan Diseases

Gayatri R. Rao, MD, JD, serves as Director for the Office of Orphan Products Development (OOPD) at FDA.

Art of Writing a Clinical Overview

Advertising and Promotion Regulatory Affairs Conference

Omni Shoreham Hotel

Medical Affairs and Scientific Communications Forum

Hilton Tucson El Conquistador Golf & Tennis Resort

Regulatory Affairs: The IND, NDA, and Postmarketing

Westin Gaslamp Quarter, San Diego

Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

Westin Gaslamp Quarter, San Diego

Regulatory Affairs for Biologics

DIA Global Center

CMC Workshop

Hilton Washington DC/Rockville Hotel & Executive Meeting Ctr.

DIA Statistics Forum

Bethesda North Marriott Hotel and Conference Center

Basics of the IND

How to Prepare for a Safety Inspection

Development of a Clinical Study Report

Regulatory Affairs: The IND, NDA, and Postmarketing

Sheraton Boston Hotel

New Drug Product Development and Life Cycle Management

Sheraton Boston Hotel

Clinical Statistics for Nonstatisticians

Sheraton Boston Hotel

Regulatory Affairs: The IND, NDA, and Postmarketing

Sheraton Philadelphia University City

Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

Sheraton Philadelphia University City

DIA Oligonucleotide-Based Therapeutics Conference

Bethesda North Marriott Hotel and Conference Center

Adaptive Design in Clinical Trials: When and How to Apply

DIA Global Center

Pharmacovigilance and Risk Management Strategies Conference

Omni Shoreham Hotel

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