Join us at this year’s conference for a great exchange of ideas, and the celebration of FDLI’s 75th Anniversary!

Lachman Consultants is excited to be part of the upcoming 2024 Food and Drug Law Institute (FDLI) Annual Conference, scheduled for May 15-16 in Washington, DC.

The conference serves as an invaluable platform for professionals across various industry sectors to converge and deliberate on the intricate landscape of food and drug law. With both in-person and virtual attendance options, the FDLI Annual Conference offers a dynamic environment that fosters dialogue, sharing insights, and staying abreast of the latest developments shaping the industry.

In attendance for Lachman Consultants at the 2024 event will be Matt Taylor, Director, Marketing & Client Engagement, along with Martin Shimer, Executive Director. You can schedule a meeting at the conference here.

At Lachman Consultants, our comprehensive suite of services is designed to assist clients as they navigate the quality, compliance, and regulatory maze. Among these capabilities, our expertise in “Expert Witness Services” is notable for our commitment to excellence and depth of knowledge in FDA regulations.

Here are some key areas in which we specialize:

      1. FDA Review Processes and Timelines: Particularly pertinent to ANDA submissions, we offer unparalleled insights into the intricacies of FDA review procedures, timelines, and actions.
      2. GDUFA I, II, and III: Our team possesses a nuanced understanding of the Generic Drug User Fee Amendments (GDUFA), ensuring compliance and strategic navigation through its iterations.
      3. Citizen Petition Process: We offer guidance on navigating the citizen petition process and understanding its impact on regulatory applications.
      4. Therapeutic Equivalence Ratings and Orange Book Procedures: Our expertise extends to therapeutic equivalence ratings, Orange Book procedures, and best practices.
      5. Exclusivity Provisions under FDCA: We provide clarity on various exclusivity provisions under the Federal Food, Drug, and Cosmetic Act (FDCA), including 3-year, 5-year, and 180-day exclusivity, as well as Competitive Generic Therapy exclusivity.
      6. Labeling Requirements for ANDAs: We offer guidance on meeting labeling requirements for Abbreviated New Drug Applications (ANDAs) in compliance with FDA regulations.


Click here to schedule a meeting with Lachman Consultants at the conference.

Join us at the FDLI Annual Conference and engage with our team to explore the wealth of knowledge and insights we bring to the table. As attendees, we look forward to this 75th Anniversary celebration as an outstanding opportunity to connect with industry peers, gain valuable perspectives from regulatory authorities, and contribute to the collective understanding of food and drug law.

Register for the conference by clicking here.