Articles

41. Case Study: Controlled Drug Handling 4/9/2010
    A midsize pharmaceutical company came to Aptuit to work through the complexities of exporting a controlled substance manufactured in the United States and an EU-sourced comparator for inclusion in a clinical trial across more than 12 EU participating countries. Aptuit’s client was dealing with an Investigative Medicinal Product (IMP) manufactured in the United States and an EU-sourced comparator. By Aptuit, Inc.
42. Poster: CMC For 505(b)(2) Applications 4/7/2010
    The Chemistry, Manufacturing, and Control (CMC) Section (Modules 2 & 3 of the Common Technical Document [CTD]) of any application to the FDA will be the cornerstone for demonstrating the quality of any drug product. A clear document that complies with the ICH Harmonized Tripartite Guideline per the ICH Steering Committee Meeting (9 Nov 2000) is instrumental to that process. By Lynn Gold, PhD, Ken Phelps, Kathryn Wekselman, PhD, RN, and Karen Seta-Aust, PhD, Camargo Pharmaceutical Services, LLC
43. Article: Improving Pharmaceutical Manufacturing Regulatory Risk 3/15/2010

    Pharmaceutical manufacturers must manage regulatory risk to ensure products are developed and produced in manner consistent with organizational goals and strategic objectives. Ongoing operations and marketplace supply can be hindered if a producer is not keenly aware of the regulatory environment and potential risks of underperforming processes. Operational requirements for development of clinical supply may also be adversely affected when regulatory issues exist. Similarly, drug development may be hindered by poorly performing production processes for managing laboratory testing, facilities and systems, quality and packaging/labeling. By ACSYS, Inc.

44. Q&A: Understanding The 505(b)(2) Approval Pathway 5/28/2009

    By the time he founded Camargo Pharmaceutical Services in 2003, Ken Phelps had already amassed more than 30 years of experience in the health science and services industry. With a broad background in drug development, specifically the 505(b)(2) regulatory approval pathway, Phelps has aided in the successful FDA approval of numerous compounds. Today, his company provides a full spectrum of drug development capabilities, from pre-clinical feasibility assessments to clinical program development to regulatory review and submission.

    In this Q&A, Phelps discusses 505(b)(2) — how it differs from 505(b)(1), its myriad of benefits, its continuing evolution, and its current and future impact on drug development.