In the life science industries — pharma research, manufacturing, medical devices and biotech — guidance and regulatory enforcement strategies are being re-evaluated with a focus on data integrity.
The journey from discovery to pharmacy is long and arduous, particularly for highly potent APIs, which must be handled in compliance with complex regulatory requirements at each stage.
The demand for generic drugs is skyrocketing. According to the US FDA, nearly 8 in 10 prescriptions filled in the United States are for generic drugs. Generic drugs can be considerably less expensive while typically providing the same level of effectiveness as brand name therapeutics. The demand is intensified by initiatives such as the Affordable Care Act that intend to lower the cost of national healthcare by compelling a move toward less expensive generics and biosimilars.
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.
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.
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:
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.
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.
This article will provide regulatory context, address confidentiality concerns, and walk through an application based on an actual FDA 483.
How the FDA regulates various product classes and the guidance documents driving regulatory enforcement varies from product to product.
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