Regulatory

  1. FDA FY2018 Drug Inspection Observations And Trends
    10/7/2019

    The FDA recently published GMP drug inspection data from CDER that addresses drug inspections conducted during the agency's 2018 fiscal year. This article examines the FY2018 data and evaluate six years’ worth of trends in FDA GMP inspection enforcement.

  2. FDA’s New Population Pharmacokinetics Guidance: What You Need To Know
    9/23/2019

    The FDA’s Population Pharmacokinetics Guidance for Industry draft calls for sponsors of new drug and biologics license applications to apply population PK analysis. This column covers the implications for drug and device manufacturers.

  3. Analysis: FDA’s Draft Guidance On Premarket Combination Products Review
    9/20/2019

    Guideline on the Quality Requirements for Drug-Device Combinations (EU) and Principles of Premarket Pathways for Combination Products (U.S.) are the latest attempts to regulate combination products. Here, we examine the two guidances in detail, beginning with the U.S. regulatory guidance.

  4. FDA Rapid Inquiry Program Takes Aim At Regenerative Medicine Compliance
    9/19/2019

    Regenerative medicine holds promise, though evidence to back claims about current therapies is underwhelming. The FDA's announcement of the Tissue Reference Group Rapid Inquiry Program returns our attention to the administration's regenerative medicine policy framework.

  5. FDA’s Top 5 Drug GMP Inspection Citations In FY2018 — With FDA Analysis
    9/16/2019

    This is the second part of a two-part article counting down the FDA’s top 10 most-common drug GMP inspection citations for the agency’s 2018 fiscal year (FY2018).

  6. Examining FDA’s New Patient Labeling Draft Guidance
    9/9/2019

    The FDA recently released the draft guidance document Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products – Content and Format. Instructions for use (IFU) are a critical element of the device user interface, and special considerations must be accounted for in their design.

  7. FDA Analysis Of The Top Drug GMP Inspection Citations In FY2018
    9/4/2019

    In this two-part article, FDA supervisory consumer safety officer Dell Moller, Office of Pharmaceutical Quality Operations (OPQO) Division 3 program director Art Czabaniuk, and OPQO Division 3 investigator Lindsey Schwierjohann present the agency’s top 10 drug GMP inspection citations for FY2018 and provide insight into the observations. This part unveils citations #10 through #6, and Part 2 will cover citations #5 through #1.

  8. Decoding FDA’s Refuse To Receive (RTR) Standards For ANDA Submissions
    8/14/2019

    Though the FDA has laid down clear steps for abbreviated new drug application (ANDA) submissions, applicants still struggle with the procedural challenges in preparing and submitting their applications. As such, it is important to dig deeper into the process and understand the possible reasons why the FDA may refuse to approve — or even refuse to receive (RTR) — an ANDA submission.

  9. 2019 U.S. State Policy Trends Impacting Pharma Manufacturers
    7/31/2019

    If the activity happening in state legislatures across the country heralds change at the federal level — and it likely does — pharmaceutical manufacturers ought to buckle their seatbelts.

  10. How To Prepare For An FDA Inspection
    7/29/2019

    An FDA inspection is very different than an ISO certification or surveillance audit — too often, organizations “prepare” for scheduled ISO audits by playing catch-up on activities that have been neglected or otherwise overlooked. The catch-up strategy will be problematic for FDA inspections.