Regulatory Compliance Featured Articles

  1. Brexit’s Impact On The Global Pharmaceutical Industry: Market Authorization & Pricing

    The Brexit referendum has resulted in instability and uncertainty for many aspects of British society, including the pharmaceutical industry. As we discussed in Part 1 of this two-part article, life sciences funding and the common market are at risk, and with it billions of dollars in research funding and imports/exports. In this article, we will explore the UK’s future relationship with the EU after exit, which will affect many facets of the worldwide pharmaceutical industry, from marketing authorization to global pricing trends.

  2. A Review Of Recently Issued EMA Annexes & Their Impact On Manufacturers

    The European Medicines Agency (EMA) is constantly adjusting its regulations, annexes, and guidances in responses to the needs of the industry, and the last 12 months have been no different. During this period they have issued a total of three revisions to established annexes and also issued a brand new guidance document in the GMP world. This article will focus on these four documents and describe what has changed and what it means to pharmaceutical companies.

  3. Overcoming Challenges In Preparing CMC Dossiers — Tips For Success

    Preparing a chemistry, manufacturing, and control (CMC) dossier can be a daunting task.  It is a detail-oriented undertaking, and as the saying goes, the devil is in the details. There are four main questions that need to be addressed for getting it right the first time:

  4. Changes To The Opioid Labeling Regulation

    FDA is revising warnings and safety information for immediate-release (IR) opioid labeling. The goal is to inform doctors better about the risks of opioids and how to prescribe these drugs safely.

  5. 3 Regulatory Guidelines For Navigating China’s Drug Delivery And Medical Device Markets

    Global spending on healthcare medicines is expected to reach $1.3 trillion by end of year 2018. While many of these medicines may be developed in the traditional dosage forms, companies are increasingly developing more and more drug delivery devices, in order to deliver patient convenience, more effective routes of administration through targeted therapies, and value to the global payors. As the world’s second largest medical device market, China offers a significant opportunity for drug delivery companies to expand their global footprint in Asia.

  6. Applying Human Performance Models In FDA-Regulated Environments

    This article will provide regulatory context, address confidentiality concerns, and walk through an application based on an actual FDA 483.

  7. Classification And FDA Regulations: Medical Device, Pharma, Combo Products

    How the FDA regulates various product classes and the guidance documents driving regulatory enforcement varies from product to product.

  8. Quality Metrics: How To Add Value And Meet The FDA's Expectations

    Quality metrics have been widely used in the pharma industry to monitor quality systems, operational processes, and to promote continuous improvement initiatives in drug manufacturing. 

  9. Payer Reaction To FDA Safety Warnings — What Pharma Manufacturers Need To Know

    On October 22, 2015, the FDA released a statement describing updated liver safety warnings for Viekira Pak. Data indicated that Viekira Pak was associated with 26 cases of medication-associated liver injury. Stakes were high in the multibillion dollar hepatitis C (HCV) market, with the fate of one of only two major competing products now unknown. Precision For Value sought to understand the payer reaction by studying payer viewpoints related to a new safety signal in the HCV space.

  10. A Primer On The 505(b)(2) Pathway For Combination Drug/Device Products

    Most combination products in the U.S. are reviewed primarily by FDA’s Center for Drug Evaluation and Research (CDER). Of these, many approvals occur via the “abbreviated” 505(b)(2) regulatory pathway. So, what is the 505(b)(2) pathway, and how can it save you time and money?