A State-of-the-Art Virtual Inspection Methodology Using Mixed Reality Technology Gets High Marks from European Medicines Agency Inspector

This is Part 2 of our four-part series on virtual inspections we review a state-of-the-art virtual inspection platform using mixed reality technology. In Part 1, former FDA executive Howard Sklamberg reviewed the current inspection landscape and what may trigger an inspection these days. In Part 3 of our series on virtual agency inspections, former FDA […]

Yes, FDA is Still Performing Pharma Inspections, Using Risk-Based Criteria: What is Your Risk for Inspection?

FDA has halted most in-person manufacturing facility inspections during the COVID-19 pandemic, but some physical inspections are still being performed—for example, for-cause inspections where the public health could be at risk or pre-approval inspections for important new therapies. FDA can also perform virtual inspections or those based on records review. How is the agency deciding […]

Microbiological Issues with Aseptic Processing and Lyophilization: CGMP Inspection Case Study by FDA National Drug Expert Ileana Barreto-Pettit

At the International GMP Conference at the University of Georgia in Athens, Georgia, in early March 2020 co-sponsored by FDA, FDA Office of Regulatory Affairs National Drug Expert Captain Ileana Barreto-Pettit presented FDA drug GMP warning letter trends over recent years and provided in-depth case studies from Current Good Manufacturing Practice (CGMP) inspections. Barreto-Pettit has […]

Inadequate Media Fills at a Sterile Manufacturer When Starting up After a Shutdown: CGMP Inspection Case Study by FDA National Drug Expert Ileana Barreto-Pettit

At the International GMP Conference at the University of Georgia in Athens, Georgia, in early March 2020 co-sponsored by FDA, FDA Office of Regulatory Affairs National Drug Expert Captain Ileana Barreto-Pettit presented FDA drug GMP warning letter trends over recent years and provided in-depth case studies from Current Good Manufacturing Practice (CGMP) inspections. Barreto-Pettit has […]

Cleaning and Cross-contamination Issues with an Encapsulator: CGMP Inspection Case Study by FDA National Drug Expert Ileana Barreto-Pettit

At the International GMP Conference at the University of Georgia in Athens, Georgia, in early March 2020 co-sponsored by FDA, FDA Office of Regulatory Affairs National Drug Expert Captain Ileana Barreto-Pettit presented FDA drug GMP warning letter trends over recent years and provided in-depth case studies from Current Good Manufacturing Practice (CGMP) inspections. Barreto-Pettit has […]

David Doleski Encourages Industry to Participate in FDA’s Emerging Technology Efforts; Sanofi Case Study Reviewed

According to FDA, we are at a “critical moment” where new technologies and emerging fields are leading to “groundbreaking” discoveries and innovative approaches to developing and manufacturing new drugs—the so-called “emerging technologies.” 1 Realizing this was the case, the agency’s strategic plan from nearly 10 years ago included its facilitation of the adoption of emerging […]

Former FDA Official David Doleski on Agency Hot Button Issues and Developing a Positive Relationship

There are perennial, overarching questions the pharma industry has regarding FDA, such as: What do they really want?What are their hot button issues?How do we develop a good relationship with them?When we have a serious issue in our manufacturing plant, should we tell FDA about it to get their help and be transparent or just […]

Avoiding and Reacting to Human Tissue, Cell, and Gene Therapy Enforcement Actions: Communication is Key

In the final two months of the calendar year 2019, FDA’s Center for Biologics Evaluation and Research (CBER) took compliance actions against human tissue, cell, and gene therapy manufacturers that included the issuance of Untitled Letters, Warning Letters, and an administrative action to cease manufacturing.These took place when the agency was in a period of […]

Part 2: Department of Justice Consumer Protection Branch Doubles in Size to Battle Fraud and Deception in the Drug and Dietary Supplement Industries

At the Food and Drug Law Institute (FDLI) Enforcement, Litigation, and Compliance Conference held in Washington, DC in December 2019, Deputy Assistant Attorney General for the Department of Justice (DOJ)’s Consumer Protection Branch (CPB) David Morrell reviewed highlights of the CPB’s enforcement work from 2019 and discussed how that work portends future action. In Part […]

How to Talk So That FDA Will Listen, and How to Listen When They Talk: Advice That Could Be Worth Millions

Getting an FDA New Drug Application (NDA) approved is pivotal to drug companies marketing in the US and marks the culmination, typically, of 12-15 years of work and an accumulated investment in excess of $2 billion.¹ According to FDA, “the documentation required in an NDA is supposed to tell the drug’s whole story, including what […]
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