ARTICLES BY ERIKA L. ROBERTS

• FDA Warns Industry Of Fraudulent & Unreliable Lab Testing Data In Premarket Submissions

  4/11/2024

  The FDA recently announced that they have seen an increase in the number of entities that contract out testing or services where the data provided by said firms was fabricated, duplicated, or just deemed “unreliable.” Here's what you can do.

• Notable Public Comments On The FDA's Proposed Regulation For Laboratory Developed Tests

  3/12/2024

  The proposed FDA regulation for laboratory developed tests marks a significant step toward the FDA trying to standardize oversight for these diagnostic tools. As the FDA seeks public input, it is a hot topic as stakeholders grapple with the implications of increased regulatory scrutiny, debating its impact on patient access, innovation, and the overall landscape of diagnostic testing in the U.S.

• Breeze Through Surprise Audits — Take These 5 Actions Now

  6/8/2023

  Summer is here! That means you might hear the dreaded words, “Surprise! We are coming to audit you!” Whether it’s a client, supplier, or regulatory agency calling for an audit, those words can strike fear in even the most organized companies. But not if you're prepared by taking these five action items now.