KASA represents an ambitious step forward for the FDA in standardizing and increasing the efficiency of the drug review process. Bikash Chatterjee writes that the challenge will be to set up risk evaluation standards that serve the spectrum of current and future drug therapy programs and leverage industry’s experience in creating and managing these systems.
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Lynn Hansen talks about strategic contingency plans, in the form of numerous government guidance/instructions developed for “a Brexit deal” or “no Brexit deal.” When the UK’s Medicines and Healthcare Regulatory Agency (MHRA) becomes the UK regulatory authority once again, it may end up obtaining a seat on International Council on Harmonization (ICH).
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Lynn Hansen points out the challenges that stem from Brexit for regulators guiding the transition for pharmaceutical, medical device, biotech, and veterinary companies, and the resources in place to ensure that the supply chain of valuable products for many patient populations can be maintained.
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Bikash Chatterjee discusses the current and potential impacts of the application of Industry 4.0 concepts to the pharmaceutical manufacturing industry, in an article in Tablets & Capsules, October 2019.
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Caitlin Bancroft of Pharmatech examines the EU draft guidance for combination products in part 2 of a two-part series in Pharmaceutical Online. Based on the new guidance issued by regulatory bodies for the U.S. and the EU, manufacturers should adjust their timelines for putting products on the market, and read and comment on the guidance.
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Designing Combination products for compliance: Caitlin Bancroft of Pharmatech analyzes the new U.S. draft guidance (part 1) and the EU draft guidance in a two-part article in Pharmaceutical Online. Regulators on both sides of the Atlantic risked falling behind when it comes to combination products that are ever increasing in complexity and capability. New EU draft guidance, and U.S. draft guidance, Principles of Premarket Pathways for Combination Products, are important. In this two-part series, Caitlin Bancroft examines the two guidances in detail.
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In an article in Pharmaceutical Outsourcing, Caitlin Bancroft of Pharmatech Associates explores several new upgrades to the 510(k) regulatory pathway implemented by the FDA. The agency’s efforts impact many different aspects of the device approval and monitoring systems, including: pre-market requirements, the use of real world evidence in applications, substantial equivalency determinations, and post-market surveillance. Two particularly impactful changes are the newly established Safety and Performance Based Pathway, and the unofficially proposed 10-year cap on predicate devices.
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Lynn Hansen, RAC, explores a basic roadmap for the process of migration to the new regulatory environment, within the 36-month timetable mandated by the FDA and ending on November 16, 2020.
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Pharmaceutical Technology spoke with Kerri-Anne Mallet, Clinical and Regulatory Affairs at Pharmatech Associates and with Bikash Chatterjee, Chief Science Officer and president; Lynn Hansen, RAC, director, Regulatory Affairs; and Caitlin Bancroft, Regulatory Affairs; all at Pharmatech Associates, about some of the differences in drug and device development, best practices for combination product development, and issues specific to Internet-connected combination products.
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Michele Levenson of Pharmatech Associates writes about risk-based validation in an expert column in Pharmaceutical Online. Depending on where your organization is on the pendulum of risk tolerance, there are many benefits to adopting risk-based validation (RBV) and ASTM E2500 within an overall validation strategy, as long as the organization is structured appropriately.
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