Regulatory

1. Improving Submission Quality: Preparing For Regulatory Differences 5/3/2021

   Pharma execs who decide to file their clinical trial applications with multiple regulatory agencies often find the global submission path attractive because of the time-saving and budget efficiencies within testing and reporting. But, if companies are not accounting for the distinct regulatory requirement differences, they could put their submission, and ultimately their product development, in jeopardy.

2. First In Line: FDA Vs. EMA Biopharma Approval Times 5/3/2021

   Most biopharmas focus on the U.S. market for their commercial strategies because of perceived greater price potential and fewer time-intensive healthcare technology assessment (HTA) processes like those in Europe. But how much impact do the approval timelines between the FDA and EMA really have?

3. The Clock Is Ticking On European Data Standards For Medicinal Products 5/3/2021

   The European Medicines Agency (EMA) has published a guide to implementing ISO IDMP data standards that will have global repercussions. Remco Munnik has been working with the EU focus group putting together the EU IDMP Implementation Guide version 2. He shares his insights and provides recommendations for business leaders.

4. FDA Inspections: Are Changes On The Horizon? 4/2/2021

   A year into the pandemic, the FDA is still conducting only limited inspections in the U.S. and evidence has emerged of a significant inspection backlog that could compromise the safety and quality of the U.S. drug supply. Kalah Auchincloss of Greenleaf Health provides a brief timeline of inspection-related events over the last year, discusses the impact, and examines the changes that we might expect as the FDA begins to shift back to normal operations.

5. FDA’s 2021 Focus Areas Of Regulatory Science: 5 Trends To Watch 3/19/2021

   The FDA recognized that a new approach was required to keep pace with the rapid evolution of science and technology driving drug development, and it released the report Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) early in 2021 to identify and communicate areas requiring continued targeted investment. These five key elements deserve our attention.

6. A Look Ahead: US FDA And Medical Device Regulations In 2021 3/10/2021

   Now that we are in 2021, what big developments can we expect from FDA in general and with regard to medical devices in particular? This article explores some of the FDA initiatives and activities worth following this year. 

7. Regulatory, Legislative Actions Set The Tone For Biosimilars In 2021 3/8/2021

   This article focuses on regulatory and legislative actions in 2020 that may impact the burgeoning biosimilars space in 2021 and beyond. In particular, the authors revisit the implications of the March 23, 2020 transition date, as well as FDA’s efforts to address biosimilar competition, interchangeability, and the COVID-19 pandemic. 

8. Achieving Business Continuity In Pharma During COVID-19 Restrictions 3/4/2021

   To ensure business continuity during COVID-19 restrictions, we developed a virtual factory acceptance testing solution that allowed SaudiVax to advance their manufacturing plan.

9. FDA Steps Up Support For Advanced Manufacturing Technologies 2/22/2021

   In its latest move to encourage the broader adoption of advanced manufacturing technologies, the FDA has entered into a memorandum of understanding (MOU) with the National Institute of Standards and Technology (NIST) that combines the strength of FDA’s regulatory expertise and NIST’s globally recognized precision characterization and standards. The MOU is significant because it takes the next step in providing much-needed guidance and resources to the industry.

10. FDA’s COVID-19 PREPP Initiative Summary Report — Key Takeaways For Manufacturers 2/19/2021

    Published in January 2021, the FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative Summary Report is the culmination of work performed by the FDA’s PREPP Initiative, which launched in April 2020 to examine lessons learned from the agency’s response to the global COVID-19 pandemic. This article provides a brief overview of the report’s overarching themes and highlights key regulatory insights for manufacturers in light of two action areas in particular.