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Regulatory Insights

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 […]