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

Have you wondered why, after an FDA inspection that is classified No Action Indicated (NAI) or Voluntary Action Indicated (VAI), the inspected firm is given a copy of the Establishment Inspection Report (EIR) relatively quickly, but when an Official Action Indicated (OAI) classification is assigned, the EIR is not sent? During a Q&A session at […]

During a Q&A session at the 2022 PDA/FDA Joint Regulatory Conference in mid-September in Washington, D.C., CDER Office of Compliance Director Donald Ashley and Office Director of the Office of Manufacturing Quality Francis Godwin provided insight regarding compliance issues in pharma companies. The following questions from attendees were among those addressed: What factors are considered […]

If your company plans to market a drug product in Latin American countries, are you aware of the CMC challenges and also opportunities in Latin America? In this article, originally published on Sept. 13, 2020, Redica Systems Senior GMP Quality Expert Jerry Chapman examines the overall drug approval process in this part of the world. […]

When it comes to decentralized clinical trials (DCTs), risk-based monitoring is just as critical as it is for in-person clinical trials. [Related: Author Jerry Chapman recently presented the webinar, “FDA GCP Inspection Trends Identified Using AI,” which included analysis of FDA enforcement trends involving clinical investigators. The recording of this webinar can be accessed here.] […]

With decentralized clinical trials (DCTs), what responsibilities fall under sponsor oversight? At the Society of Quality Assurance 2022 Annual Meeting in Palm Springs, Calif. FDA Office of Regulatory Affairs Bioresearch Monitoring Division I Director Anne Johnson provided FDA’s perspective on DCTs in a presentation titled, “Sponsor Oversight of Decentralized Clinical Trials.” [Related: What can inspection […]

During the recent pandemic, as with many facets of life and business, the design and conduct of clinical trials adapted to limit physical contact between individuals—in this case, those conducting and participating in clinical studies. Many companies opted to use a format that has been around for some time but not frequently used: the Decentralized […]

The Critical Role of Management Engagement in Quality Culture What can regulatory documents and FDA Warning Letters issued in 2021 tell regulated industries about data integrity trends? And why should industry leaders develop a data culture mindset? During a session at the 2022 PDA Annual Meeting, Ulrich Köllisch, PhD, Manager of Data Integrity at GxP-CC, […]

Over a four-year period, FDA issued five warning letters to a physician and associated entities and organizations—one from CDER for marketing unapproved new drugs, and four related to clinical studies under the Bioresearch Monitoring (BIMO) Program. This is the first time a single individual or entity has received four BIMO warning letters, all for different […]

In a six-year collection of FDA warning letters issued to clinical investigators (CIs) of human studies, the Redica Systems Expert Model for GCP confirms that “protocol compliance” is the most common category of observation involving “responsibilities of the investigator”—and “dosing issues” is the largest subcategory under “protocol compliance.” [Related: For more analysis of FDA GCP […]

In 2021, FDA issued its first three official notices of noncompliance on the clinicaltrials.gov website for failure to comply with reporting obligations. Two were issued to clinical trial sponsor companies and one to an individual—a sponsor investigator. These represent the first such warnings since the regulations for the human clinical trials database were implemented in […]