Regulatory Compliance Featured Articles

  1. Optical Rotation And Quality Control

    The optically active pharmaceutical and its mirror image are referred to as enantiomers. While they might possess identical physical properties, their physiological properties can differ dramatically. 

  2. Excipients And SAXS: The Detection Of Structural Aging

    A solution to obtain structural information quickly for effective quality control of pharmaceuticals during production or to study ageing effects and other properties.

  3. New Regulations And Safety Complicate Drug Labeling

    Multinational pharmaceutical companies have for decades manufactured drugs for global distribution. Nevertheless, the task of labeling is becoming increasingly difficult and time-consuming. 

  4. Analyzing 2017 FDA Warning Letters Citing Process Validation, Supplier Controls, & OTC Manufacture

    Shortcomings in data governance/data integrity and are a prominent feature in drug GMP warning letters over the past three years. FDA inspections also focused on contracted services. Additional areas were the subject of FDA investigator attention in CY2017 but may have been overshadowed by these two. This article explores several of those other areas.

  5. An Analysis Of 2017 FDA Warning Letters On Data Integrity

    Enforcement of failures in data integrity and data governance began almost 20 years ago and continues to increase in visibility and number of warning letter enforcement actions. While the FDA is not the only health authority that identifies these issues in inspections and enforcement actions, its transparency ensures the data is available.

  6. FY2017 FDA Drug Inspection Observations And Trends

    This article presents the most recent publication of GMP drug product inspection data from the FDA's Center for Drug Evaluation and Research (CDER), which addresses drug inspections conducted in FY2017. It looks at five years of data from the FDA, examines data from 2017, and evaluates five years’ worth of trends in GMP inspection enforcement.

  7. Too Little Or Too Late? Perspectives On FDA’s New Serialization Guidances

    Looking forward, the U.S. pharmaceutical industry needs to be aware that the despite the FDA’s year-long delay in enforcement, the Drug Supply Chain Security Act (DSCSA, with its specific compliance deadlines, is still law and that it is only draft guidance from the FDA that identifies an intent not to enforce the DSCSA for one year.

  8. An Analysis Of Regulatory Reforms In China’s Pharmaceutical Market

    Over the past year, sweeping regulatory reforms have been introduced in China with the aim of encouraging innovation and reducing regulatory burden on the life sciences industry. The breadth of these reforms spreads across multiple stages of the drug development life cycle.

  9. 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.

  10. Why You Should Engage With Regulatory Early In Product Development

    Involving regulatory affairs early in the development process facilitates execution of the development pathway while considering both regulatory requirements and the company’s business needs.