Regulatory Insights

The Fundamentals of Immunization, Part 3

The race to develop a safe and effective vaccine against COVID-19 is on, and it has everyone talking. This is the third of my three-part series on the fundamentals of immunization. Part 1 of the series reviewed and clarified fundamental terms that are central to the conversation and provided answers to some of the most […]

The Fundamentals of Immunization, Part 2

The race to develop a safe and effective vaccine against COVID-19 is on, and it has everyone talking. This is the second of a three-part series on the fundamentals of immunization. Part 1 of the series reviewed and clarified fundamental terms that are central to the conversation and provided answers to some of the most commonly […]

The Fundamentals of Immunization, Part 1

Inoculation, vaccination and immunization are terms that are often used interchangeably, but have very different meanings. This leads to the question, “How much does the average person understand about the science of immunization?” The race to develop a safe and effective vaccine against COVID-19 is on, and it has everyone talking. This blog will be […]

Weighing FDA’s Response to the COVID-19 Pandemic

A Comprehensive Review My last installment discussed observations regarding long overdue changes to Title 21 needed to promote innovation and flexibility in response to local, regional and global stressors such as the current COVID-19 pandemic. While we await legislative acts that will hopefully modify and modernize Title 21, this installment will highlight some of the […]

How Coronavirus, Brexit, and Hurricanes Are Impacting the Global Supply Chain

Global Supply Chain Risk Exposed By COVID-19 In 2017, Hurricane Maria damaged the Puerto Rican power grid and caused worldwide shortages of IV saline fluids that lasted over a year. In 2019, Brexit and U.S. trade tariff negotiations raised questions about the stresses geopolitics can apply to fragile globally interdependent supply chains. Currently, the impact […]

In a Data-Driven Ecosystem, Don’t Let Data Integrity Be Your Achilles’ Heel

It’s a Global Concern; Our Data Has Integrity Issues Agencies tasked with regulating and monitoring medical therapies have an enormous responsibility to the citizens of the world. They are tasked with creating and enforcing consumer centric regulations without creating a regulatory burden for manufacturers that could threaten product availability or medical progress. The challenges they […]

The Food Safety Modernization Act

The Food Safety Modernization Act (FSMA) is the first major expansion of federal food safety laws since 1938. FSMA expands the Food and Drug Administration (FDA) powers broadly and establishes relationships between FDA, USDA, the CDC and DHS in order to more effectively and proactively prevent food safety problems, detect and respond to food safety […]

Part 2: The Evolution of the Clinical Trial; Is Ethnopharmacology the New Frontier?

Last month, Part 1 of this series reviewed the history of some of the protections provided to the American consumer by Title 21 and the Food and Drug Administration.  Last month’s installment focused on the development of the controls designed to evaluate the impact of utilizing our medicines in clinical situations; the history of Clinical […]

Part 1: The Evolution of the Clinical Trial – Is Ethnopharmacology the New Frontier?

Today’s American consumer is accustomed to the protections provided them by The Food and Drug Administration, protections that ensure the medicinal products we are exposed to are pure, safe, and effective. However, the current model of consumer protection applied to medicinal products has been, and continues to be, a product of evolution of knowledge, attained […]

The Biggest Story of 2012? Innovation!

Examining the past with an eye on improving the future is something everyone does as a calendar year comes to a close.  This month’s blog will honor that tradition, focusing on the future challenges and the past achievements of our industry. One of the largest challenges our industry faced in 2012 was the economic impact […]

FDA Enforcement Priorities and Methods

AN OVERVIEW US law has regulated food production since the 1800s, along with food additives and drugs since the early 1900s. The Federal Food, Drug, and Cosmetic Act of 1938 (“FD&C Act”) was the first modern comprehensive regulatory regime, and created the FDA to administer and enforce these laws. Today FDA regulates over $1 trillion […]

Food and Drug Regulations; Too Many, Too Few, or Just Enough?

In light of the recent and well publicized drug shortages, the national debate on healthcare costs, and the slowing pace of new drug approvals, we felt the American consumer might appreciate a blog dedicated to the current relationship between drug manufacturers, the FDA, and Title 21. Federal Regulations and Consumer Protection: A Primer for the […]

Pharmaceutical Patents: Innovation and Product Pricing; Helping or Hurting?

Every member of our industry is aware of the significance of the high profile patent expirations that have occurred in 2011, and will occur in 2012.  Twenty of those expirations impact blockbuster products, whose profit margins were substantial sources of revenue for development activities.  While the relationship between profits generated by drugs protected by patents […]

Inspection and Enforcement Trends: How Well Do You Know Your CRO?

Inspection trends indicate that The U.S. Federal Drug Administration (FDA) has increased the number and rate of inspections of Contract Research Organizations (CROs) by nearly 300% in recent years.  Additionally, FDA (CDER, CBER, and CDRH) centers published an updated Guidance Document on this topic in March of 2011 (USFDA Compliance Program Guidance Manual 7348.810 for […]

New York State: A Leader in the Life Sciences

New York State has an impressive history and a long tradition of leading the nation in industry, innovation, and growth.  The role of NYS in the Life Sciences is no exception. New York State has served as home to many high profile life science companies, colleges, and research institutions.  Even before Charles Darwin published Origin […]

Constitutionality of The GMPs; Another Challenge

The federal regulations collectively referred to under Title 21 as “the GMPs” are unique portions of our federal code.  Their uniqueness lies in the broad language used by the legislators who constructed them. This type of language differs widely from other regulations issued at the federal level, which are generally specific, including extensive detail. While […]

Collaborate and Innovate!

Currently, the United States is the world’s leader in Medical Device innovation.  The pace of innovation continues to increase rapidly.  However, the development, clinical testing, and review/approval process required by Title 21 is lengthy, expensive, and can be seen as an impediment to the pace of advancements of medical technology. While the United States leads […]

FDA, Transparency and Market Place Improvement

In June 2009 the Federal Drug and Administration (FDA) responded to President Obama’s commitment to promote transparency and openness in the government by launching an internal Transparency Initiative.  The Initiative’s objective was to develop mechanisms that would promote the disclosure of information online to the public. Toward this end, the U.S. FDA created a task […]

ICH and FDA: A Valuable Cooperative

In the interest of promoting public health and safety, one of the U. S. Federal Drug Administration’s (FDA) continual goals is to foster the advancement of the global harmonisation of regulatory requirements and practices.  The relationship between the FDA and the ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human […]

FDA, Transparency, and Consumer Protection

Most people are aware that the FDA is a federal agency and its mission is to protect the health and safety of the American public.  What many people fail to realize is that FDA inspectors are federal agents.  FDA agents are sworn into duty, taking an oath to protect health and human safety.  Since its […]

FDA’s Attempts to Implement Continual Improvement Efforts; The 2011 Budget

The Food and Drug Administration, an administration within the Health and Human Services division of the executive branch of the United States federal government, is responsible for protecting public health by “assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, our nation’s food supply, cosmetics, dietary […]

Agribusiness and Governmental Oversight

In May, the Centers for Disease Control identified a nationwide increase in the number of salmonella cases documented in the United States.  Approximately three months later Wright County Egg voluntarily conducted a nationwide recall of shell eggs from three of its five farms. The recall was expanded to all Wright County Egg farms on Aug. […]

One Year Anniversary of Tobacco Control Act

In 2009 the United States Congress completed a long rumored expansion of Title 21.  This was manifested via the Family Smoking Prevention and Tobacco Control ACT (Tobacco Control ACT), which was codified into law last year(1).  This article will review the purpose of the ACT, reflect on the actions taken in the past year, and […]

FDA: Improving Strategy for Ensuring Integrity of Clinical Data

Clinical data management is generally understood to mean a process of implementing a reliable method for collecting, processing, managing, and conveying data in a manner that protects subjects’ rights, and insures data integrity.  Historically, regulations intended to ensure the integrity of clinical data are contained within 21 CFR 312. The ability to falsify data is […]

Gulf Spill, Industrial or Governmental Failure?

In the last few weeks (57 days) an overwhelming amount of information has been pouring into the media with regard to British Petroleum’s deep water rig explosion. As a Quality Systems professional, whose job it is to assure the control of processes and the eventual outcome of them, I wanted to do my own research […]

The USFDA Launches Initiative to Reduce Infusion Pump Safety Risks

The U.S. Food and Drug Administration has announced a new initiative to address what FDA’s Center for Devices and Radiological Health (CDRH) has referred to as “rampant” safety issues associated with the technology utilized by external infusion pumps. CDRH Director Jeffrey Shuren has called this a first for the agency, exercising its authority over an […]

FDA Launches Initiative to Provide Oversight to Home Use Medical Devices

The U.S. Food and Drug Administration today announced a new initiative to ensure that caregivers and patients safely use complex medical devices in the home. The FDA hopes that The Home Use Initiative will help address the potential challenges, by providing greater protection and awareness for patients who are being cared for in the home. […]

Warning Letters: Roadmap to Corrective Action

Facilities should understand the importance of this “early-warning” message from FDA. Following an unsatisfactory facility inspection, the FDA has the ability to give individuals and firms an opportunity to take voluntary and prompt corrective action in response to deficient findings before it initiates an enforcement action. FDA uses the Warning Letter to achieve voluntary compliance […]

FDA’s Approach to Globalization

On Feb 4, 2010, Dr. Margaret Hamburg explained in detail the enormous problem facing the FDA. Globalization has made the task of monitoring imports and suppliers daunting and nearly impossible. The huge number of products imported, the vast number of foreign companies that create regulated products, and the increased complexity of the supply chain from […]

Proactive Agency Initiatives Promote the Development of Treatments for Rare Diseases

As we all know, the cost of developing drug therapies, clinically evaluating effectiveness and then scaling up production facilities, is considerable. Recent figures suggest that prior to release to the public, investments by industry can exceed $800 million USD. Eventually, when these therapies reach the market place, they must be priced accessibly, and recoup not […]

Enforcement Actions Rising

Recently, expanding global markets and increased volume of products has increased the real and present threat to consumers, as can be seen by recent public health issues; • lead based paint used by Chinese toy manufacturers, • deadly excipients in veterinary food products, • salmonella outbreaks in spinach and peanut products, and • Heparin contamination. […]


As the end of the year is approaching and plans are made for next year, it is important to be aware of the current strategy and budget of the FDA. The past five years have revealed a continuous decline in injunctions, warning letters and inspections from the FDA. The projections for 2010, however, clearly reveal […]

Follow The Money

 To discover a person’s priorities, discover how they spend their money, to know what a person values, know how they spend their money, to find the truth, follow the money. In this time of growing concern for the health and safety of the American public, the outcry with regard to the performance of the Food […]