GUEST COLUMNISTS

• 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.

• Life Sciences Deal-Making Gets Creative, Aims At Early Stages Amid COVID-19

  Life sciences companies remain unabated when it comes to creatively making deals during the COVID-19 pandemic, particularly among those targeting biopharma companies with early-stage assets. Check out this article highlighting takeaways from the KPMG 2021 Healthcare & Life Sciences Investment Outlook, which tallied 1,138 acquisitions, licensing, and R&D deals announced in 2020.

• Complying With Batch Release: Auditing Electronic Batch Records

  This article presents some advice for auditing electronic batch records to assess their current good manufacturing practice (cGMP) status. This is useful in the qualification stage and essential once the electronic record system is in operation. 

• Medicare Braces For Expanded Use Of High-Cost CAR T-Cell Therapy

  The Centers for Medicare & Medicaid Services (CMS) established a new reimbursement rate for inpatient CAR T-cell delivery in 2021 designed to more closely reflect the true costs of care and address the financial losses experienced by many healthcare institutions. This article delves into details on this and also discusses another significant change for 2021.

• 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.

• Establishing An Effective Calibration Program

  Calibration is the comparison of inspection, measuring, and test equipment against a traceable reference device to determine if accuracy and precision limits are met. It is one of the fundamental, yet often neglected requirements for GMP. Several international standards, regulations, and guidances provide requirements for an effective calibration program.

• A Checklist For Risk Assessment Of Nitrosamine Impurities In Oral Solid Dose Drugs

  Nitrosamine impurities such as N-nitrosodimethylamine (NDMA) are being identified in high-volume drug products such as valsartan, losartan, irbesartan, and ranitidine at levels well above the acceptable daily intake limits. The credit for identifying the higher NDMA levels goes to an independent pharmacy that tests every batch it dispenses, exposing limitations in drug substance and drug product post-approval change assessment and analysis requirements at pharmaceutical manufacturing organizations. 

• Applying QbD To Incorporate Excipients Into Drug Lifecycle Management

  This article is the third in a three-part series based on information from the new guide Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design, published by the International Pharmaceutical Excipients Council Federation (IPEC Federation). In addition to life cycle management, the article delves into continued monitoring, multivariate analysis, continued product verification, and more.