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

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 […]

Did you know that FDA sometimes holds regulatory meetings to discuss a Voluntary Action Indicated (VAI) or Official Action Indicated (OAI) inspection outcome with the inspected drug manufacturer? What is the purpose of these meetings and how do they differ from one another and other regulatory meetings? While many are familiar with the Types A, […]

In the rapidly evolving world of medical technology, staying ahead of regulatory changes, understanding product performance in the real world, and ensuring patient safety are top priorities for every product license holder. To help MedTech companies meet these demands, we are excited to introduce Redica Systems’ latest product: Postmarket Intelligence. We are launching Postmarket Intelligence […]