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 […]
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 […]
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 […]
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 […]
Top Reasons Why FDA Inspections Often Fail
Why do good manufacturing operations have inadequate FDA inspections? FDA warning letters and 483s are rife with references to manufacturing controls and batch failures, SOPs and QC procedures, complaint handling, and CAPA investigations. But in many, perhaps even most cases, the root cause is not an actual failure to meet regulatory requirements in these areas, […]
Writing for FDA Compliance Success: The Greatest Problem No One Talks About
There are no FDA regulations governing writing quality or clarity. FDA Investigators will never note “poor writing” as a 483 observation or warning letter citation. But when it comes to regulated manufacturing operations, the FDA’s rule of thumb is that if it wasn’t documented, it didn’t happen. In this article we we talk in detail about […]
Crucial Steps for Preventing Batch Failures and Protecting Your Business
Preventing batch failures and protecting your business is crucial to success within the manufacturing industry. Insights from In-Pharmatechnologist.com (dated 4/25/2012) shed light on revelations from the FDA’s 2011 Warning Letter data. According to the report: “In fiscal 2011, the US Food and Drug Administration (FDA) sent biopharma manufacturing-related warning letters to 52 facilities. Close to […]
Why CBD Manufacturers Should Develop GMPs Even if Absent FDA Instructions
Cannabidiol (CBD) is the latest “it” product. Companies across the US and internationally are eager to manufacture or incorporate CBD into various other products. Despite a Draft Guidance issued by the FDA on July 22, 2020 (85 FR 44305) entitled Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, a mountain of uncertainty still exists regarding […]
