<span class="archive__title-prefix>Posts Categorized:</span> Blog

A review of the 2024 MedTech device-related adverse events and product issues for 2024 as revealed by FDA’s MAUDE (Manufacturer and User Facility Device Experience) database and analyzed using Redica Systems reports shows events and trends worth highlighting, in particular for integrated continuous glucose monitoring (iCGM) systems and CPAP machines. First a few caveats. Reports […]

In 2011, drug shortages captivated the United States’ attention as an emerging public health crisis, as the number of reported shortages tripled between 2005 and 2011.1 With this alarming data, the Obama Administration took action to protect the public against worsening drug shortage conditions. On 31 Oct 2011, Executive Order 13588 – Reducing Prescription Drug […]

Keeping medicines safe, effective, and available for all Americans is an important goal with broad bipartisan support. However, the agency tasked with achieving that goal, the U.S. Food and Drug Administration (FDA), is facing increasing challenges. FDA leaders have recently been called before Congressional committees to testify on matters ranging from preventing drug shortages to […]

At the PDA/FDA Joint Regulatory Conference 2024 held in Washington, DC, September 9-11, 2024, FDA Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) Office of Pharmaceutical Manufacturing Assessment (OPMA) Senior Pharmaceutical Quality Assessor Dr. Madu Dharmasena provided her insights on CDER’s regulation of biologics products. In addition to its responsibility for […]

In the average scenario, at least $300,000 per observation Operating with poor quality is going to cost your firm. It’s not just the staff hours it takes to respond to a Form 483 or facilitate an FDA inspection, but the total of these “ordinary” costs, plus a variety of less recognized, hidden costs. Each 483 […]

In today’s rapidly evolving pharmaceutical and medical technology industries, combination products represent a significant area of growth and innovation. These products, which integrate drugs, devices, and biological products, offer new therapeutic possibilities but also present complex regulatory challenges. Navigating the U.S. Food and Drug Administration’s (FDA) guidelines is crucial for manufacturers aiming to bring […]

Introduction: ICH Q9 In the highly regulated pharmaceutical and medical technology (medtech) industries, maintaining quality standards is a top priority. Quality Risk Management (QRM) is a systematic process for identifying, assessing, controlling, communicating, and reviewing risks to the quality of a product. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use […]

A July 29 to August 2, 2024, FDA inspection of API manufacturer Global Calcium Pvt. Limited, in Hosur, Tamil Nadu, India, revealed that blatant data falsification and manipulation continue to take place at factories that supply drugs to the U.S. market. The five-day inspection by FDA investigators Justin Boyd and Teresa Navas resulted in a […]

Common questions across the pharma industry since the business model shifted years ago to contracting out manufacturing and supply chain operations include, “Who is responsible when current Good Manufacturing Practice (CGMP) regulations are not followed? Which entity is subject to enforcement actions by regulatory agencies including 483s and warning letters?” Those questions were explored by […]

Introduction: Overview of 21 CFR Part 820.30 In the highly regulated landscape of the pharmaceutical and medical technology industries, maintaining compliance with federal regulations is paramount. One such critical regulation is 21 CFR Part 820.30, a subsection of the Code of Federal Regulations (CFR) that specifically addresses design controls for medical devices. This regulation outlines […]