White Papers: Regulatory Affairs

• Designing — and Planning — for an Accelerated FDA Review

  September 27, 2022

• Expertise and Communication Support for Complex Innovative Trial Design (CID) Success

  June 10, 2022

• SOPs: Least Understood, Most Important Tool to Ensure Regulatory Compliance

  October 4, 2011

  Learn the most common issues with SOP creation, management and implementation and solutions.

• Resolving Scientific Disputes With FDA: Regulatory Processes and Practical Tips

  March 1, 2011

  Learn the processes for initiating an appeal, escalating a dispute and dealing effectively with the FDA.

• Meeting With FDA Can Increase the Probability of Product Approval

  October 1, 2010

  Formal meetings with reviewers at the U.S. Food and Drug Administration (FDA) are among the most important and useful resources available to sponsors of medicinal products seeking marketing approval in the U.S.

• Biosimilars: Past, Present and Future

  April 13, 2010

  Learn the regulatory history, new proposed development pathways, realities and myths about biosimilars, the politics involved and what the future holds.

• The 505(b)(2) Drug Development Pathway: When and How to Take Advantage of a Unique American Regulatory Pathway

  April 6, 2010

  The 505(b)(2) regulation offers a less expensive and faster new drug development pathway that may be particularly attractive to a manufacturer with experience in developing generic products.

• Forecasting for Success: The Power of Regulatory Gap Analysis

  December 1, 2008

  A gap analysis is a powerful tool that can be used to forecast a particular product’s success.

• Considering Outsourcing? Risks and Benefits for FDA-Regulated Firms

  October 14, 2008

  Learn the four keys to an effective outsourcing strategy.

• The Promise of Biogenerics: Hope and Hype

  January 8, 2008

  Generic biologics hold great promise. It is inevitable that regulations for biosimilars or follow-on biologics will be implemented in the near future.

• Regulatory Considerations for Conducting Clinical Trials in India

  March 26, 2007

  Learn the history of Indian drug regulations, current regulatory processes and practical issues in outsourcing drug discovery and clinical development programs to Asia, particularly India.

Other Resources

• Oncology Clinical Trials: An Emerging Paradigm Shift in Study Design

  April 27, 2022

  This white paper explains the different study designs for clinical trials and the emergence of master protocols as a way to simultaneously evaluate multiple drugs and/or disease populations in multiple studies. Find out the key features of master protocol trial designs, including the practical and statistical challenges associated with designs of this type.

White Papers: Development Strategy

• Beyond a Requirement: The Value of Highlighting Postmarketing Safety Efforts

  October 20, 2021

  PMS plan helps refine future trials for better direct drug discovery efforts and required prior to reaching market approval from regulatory agencies like FDA.

• Understanding Adaptive Designs for Clinical Trials

  April 21, 2020

  This white paper provides an overview of adaptive design in clinical trials, including its history and current application in the pharmaceutical and biotech industry.

• Risks and Benefits of Conducting Preclinical Studies in the Global Setting

  December 20, 2011

  It is generally accepted that the preclinical studies needed for first-in-man clinical studies usually take one to three years and cost up to $10 million USD.

• Global Development of an Innovative Medical Device for the U.S. Market

  December 13, 2011

  Creating a new medical device based on new technology is a daunting task.

• Development of Wound Management Products for the U.S.

  December 6, 2011

  Wound care products are primarily aimed at ensuring timely wound healing and effective infection control.

• Strategies for Implementing the New GMPs for Dietary Supplements

  February 8, 2011

  In the last few years, there has been increasing interest in the pharmaceutical industry in outsourcing drug discovery and clinical development programs to Asia, particularly India.

• Developing Botanical Products from India for the U.S. Market

  August 4, 2009

  With only 10% of the Earth’s estimated 250,000 species of plants considered medicinal, botanicals are the “sleeping giant” of drug development.

• Developing Traditional Chinese Medicines as Botanical Drugs for the U.S. Market

  August 1, 2009

  Therapeutic products derived from medicinal plants have been used throughout the history of mankind.

• Regulatory Harmonization Efforts in India: Keeping in Step With the Globe

  June 10, 2008

  The Indian pharmaceutical industry has established itself as a key player in the manufacturing arena, with almost half of the active pharmaceutical ingredients (APIs) worldwide being produced there.

• Designing a Global Product Development Strategy

  June 3, 2008

  Pharmaceutical products are truly global in nature—not only in terms of usage but also in terms of the strategic location of different development activities.

Assessments

• Are you ready to submit your IND/IDE application to the FDA?

  August 5, 2021

Webinars

• Oncology Clinical Trials: An Emerging Paradigm Shift in Trial Design

  October 27, 2020

  This webinar reviews several newer clinical trial strategies such as combining adaptive trial designs with innovative endpoints.

• Upgrading the FDA Adverse Event Reporting System (FAERS) Based on ICH E2B (R3) Standards

  April 7, 2020

  Shide Badri, M.D., summarizes upgrades to electronic submission of individual case safety reports in FAERS, FAERSII’s implementation timeline, and benefits and impacts.

Publications

• One Year of Regulatory Training Abroad: Korean MFDS Staffer Working at U.S. CRO Shares Her Experience

  September 8, 2020

  The Korean Ministry of Food and Drug Safety (MFDS) has a number of international cooperation programs designed to help key staff better understand global medical product development practices.

• Mortality and Long-Term Functional Outcome Associated With Intracranial Pressure After Traumatic Brain Injury

  August 3, 2012

  We have examined whether raised elevated intracranial pressure (ICP) is independently associated with mortality, functional status and neuropsychological functioning in adult traumatic brain injury patients.

• Craniofacial Variables in Subjects With and Without Habitual Snoring: A Cephalometric Comparison

  September 1, 2010

  The aim of this case control study was to evaluate which cephalometric variables related to craniofacial morphology discriminate between snoring and non-snoring or any other respiratory disease subjects.

• Evaluation of 278 Hla-b27 Positive Patients Suspected of Seronegative Spondyloarthropathies

  October 1, 2007

  To determine HLA-B27 prevalence in patients suspected of Seronegative spondyloarthropathy referred to the Transplantation Department of Blood Transfusion Organization, and to evaluate clinical findings among HLA-B27 positive patients.