MIT COUHES IRB Warning: Ensuring Compliance in Research
In the realm of clinical research oversight, adherence to regulatory standards is not merely a recommendation but a fundamental obligation. Recently, a significant development underscores this imperative, as the Massachusetts Institute of Technology’s Committee on the Use of Humans as Experimental Subjects (MIT COUHES) Institutional Review Board (IRB) received a warning letter from the FDA […]
Breaking down FDA’s Guidance on Delaying, Denying, Limiting, or Refusing an Inspection
The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and efficacy of drugs and devices. One of the key aspects of their oversight involves inspections of facilities where these products are manufactured, processed, packed, or held. The FDA’s guidance on what constitutes delaying, denying, limiting, or refusing an inspection […]
Navigating the Evolving Landscape: Pharmaceutical Manufacturing Trends
Hello again, everyone. Welcome to another episode of Executive Platforms’ Blueprint Podcast Series. I’m Geoff Micks, Head of Content and Research. Today, Teresa Gorecki from Compliance Architects joins me. We’re discussing current issues and pharmaceutical manufacturing trends. Teresa’s insights from last year set a high benchmark, and I’m excited to continue our conversation. Read the […]
From Crisis to Compliance: The Strategic Overhaul that Prevented DOJ Action
Maintaining a regulatory compliance strategy is crucial for any company’s sustainability and success in a rapidly evolving regulatory environment. When faced with substantial challenges, Compliance Architects (CA) demonstrated their expertise by successfully rescuing a company from potentially being sent to the Department of Justice (DOJ) for numerous FDA warnings in just 9-12 months. This blog […]
New FDA Guidance on Facility Readiness for ANDA Submissions
The U.S. Food and Drug Administration (FDA) has issued new guidance detailing how it will assign goal dates for abbreviated new drug applications (ANDAs) based on facility readiness for inspection. This move, outlined in the Generic Drug User Fee Amendments (GDUFA) III commitment letter for fiscal years 2023-2027, aims to streamline the review process and […]
The Loper Bright v. Raimondo Decision: Navigating the Double-Edged Sword of Reduced Federal Regulatory Power
Based on my recent discussions with clients and industry stakeholders, the consequences of the Supreme Court’s recent Loper Bright v. Raimondo decision have become significant speculation within the FDA-regulated industry. Loper Bright—or, as I refer to it, the “Compliance Consultant and Lawyer Reauthorization Act of 2024″—signals a profound shift with far-reaching and uncertain implications for […]
New Medical Device Regulations with the Recent FDA Rule on Harmonization
Our practice lead, Teresa Gorecki, recently shared her LinkedIn article that addresses new medical device regulation changes with a recent FDA rule on medical device regulation harmonization. The article below shares information on the change, what it means, what we know, and what we should do. Introduction Those of us working in the Medical Device […]
Streamlining Drug Development: FDA’s Advanced Technology
The U.S. Food and Drug Administration (FDA) has introduced industry guidance that outlines the Platform Technology Designation Program, designed to bring efficiencies to drug development, manufacturing, and review processes. This program, established under section 506K of the Federal Food, Drug, and Cosmetic Act (FD&C Act), provides a pathway for sponsors to leverage data from designated […]
Collaborations in Quality Assessments and Inspections
In a new development for global pharmaceutical regulation, the FDA and the European Medicines Agency (EMA) recently collaborated for the first time on quality assessments and inspections under a pilot program started by the International Coalition of Medicines Regulatory Authorities (ICMRA). The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) served as an observer during this […]
Navigating FDA Regulations Post-Pandemic: Interesting Insights from Teresa Gorecki
We enjoyed our very own Teresa Gorecki, Practice Lead at Compliance Architects, speaking with Geoff Mix, Head of Content and Research for Executive Platforms, when we attended the Pharma Manufacturing World Summit 2023. In this interview, Geoff talked to Teresa about the latest developments in FDA regulations post-pandemic in the United States. They explored the […]
