FDA Featured Articles

  1. Elemental Impurities: Steering Clear Of The Big Four

    With new regulations having established a need for the testing of certain elements, correct sample preparation is crucial.

  2. Business And Cultural Considerations When Managing Clinical Supplies For Asia-Pacific Studies

    In addition to careful adherence with all applicable regulatory and Customs requirements, sponsors should understand and be sensitive to the cultural and business norms of each country included in their study.

  3. Navigating The Marketing Authorization Process In Europe

    To be able to market a medicinal product in Europe, you must obtain a Marketing Authorization (MA) from the relevant regulatory authority. There are a number of different routes to apply for an MA.

  4. Regulatory Guidance and Engineering For Sterile Drug Manufacturing Facilities

    This article provides an overview of the regulatory guidelines and the fundamental GMP requirements with regards sterile manufacturing of medicinal products, with a particular focus on engineering aspects.

  5. Understanding And Delivering Your EU Orphan Drug Launch

    Although the European marketplace presents a significant opportunity for innovative orphan drug companies to meet unmet patient needs, launching your drug product can present a real challenge.

  6. Autologous Cell Therapies At Crossroads With FDA: What To Do Now?

    Regulatory controls on local collection and processing of autologous cells present a major challenge to clinics that want to provide individualized therapies. How can pharma overcome the hurdles?

  7. What Does "Child Resistant Packaging" Mean In Pharma?

    Child resistant packaging intergrates the use of safety mechanisms and physical barriers to reduce the risk of poisining in children via the ingestion of potentially hazardous medicines.

  8. Incorporate Data Integrity Into Your Pharma Quality Management System

    A viable QMS cannot be based upon anything except data and records that are attributable, legible, contemporaneous, original, accurate, complete and easily retrievable. 

  9. Managing GxP Environmental Systems To Ensure Data Integrity

    In the life science industries — pharma research, manufacturing, medical devices and biotech — guidance and regulatory enforcement strategies are being re-evaluated with a focus on data integrity.

  10. Perfect Potent API Processing: Handling Hazardous Drug Actives Effectively

    The journey from discovery to pharmacy is long and arduous, particularly for highly potent APIs, which must be handled in compliance with complex regulatory requirements at each stage.