REGULATORY ARTICLES

  • Navigating DSCSA Implementation: Key Requirements & 4 New FDA Guidances

    In the U.S., you're grappling with how to set up a fully interoperable electronic system for securing and tracing products across industry sectors per the Drug Supply Chain Security Act (DSCSA) by Nov. 2023. Here's how to navigate the key requirements, as well as the FDA's four new guidances on the subject released in June.

  • New US Legislation Creates Momentum For Biosimilars

    Most biosimilars (follow-on biologic products) still only have shares below 50% in the U.S., which is far different than market shares in Europe. One major reason is a mistrust around biosimilars’ safety and efficacy. Congress has stepped in to address that issue through the Advancing Education on Biosimilars Act of 2021, with the goal of encouraging rapid uptake soon after biosimilars become commercially available.

  • FDA’s Longtime Approach To New Chemical Entity Designations Now Codified

    New chemical entity (NCE) designations are extremely important to small molecule pharmaceutical developers: they provide a five-year exclusivity period assuring no competition to a new drug product from generics, with or without patent protection. Recently, President Biden signed into law the Ensuring Innovation Act to clarify when a new drug may be granted NCE status.

  • Improving Submission Quality: Preparing For Regulatory Differences

    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.

  • First In Line: FDA Vs. EMA Biopharma Approval Times

    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?

  • The Clock Is Ticking On European Data Standards For Medicinal Products

    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.

  • FDA Inspections: Are Changes On The Horizon?

    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.

  • FDA’s 2021 Focus Areas Of Regulatory Science: 5 Trends To Watch

    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.

  • A Look Ahead: US FDA And Medical Device Regulations In 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. 

  • Regulatory, Legislative Actions Set The Tone For Biosimilars In 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.