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.

• FDA Issues Final Guidance: Reformulating Drug Products That Contain Carbomers Manufactured With Benzene

  2/6/2024

  Benzene contamination in pharmaceuticals has led to product recalls and increased scrutiny in recent years. Recently, the FDA has asked the USP to remove a few monographs from the compendium due to safety concerns related to benzene's carcinogenic properties, and the agency has issued a new guidance to help industry navigate the reformulation of such drug products.