Expanded Access to Investigational Drugs – Not Just About Being “Compassionate”


Expanded access use of drugs in development (also commonly known as “compassionate use”) is an issue that has come to the forefront recently with some high-profile cases involving the news media and social media. Many may recall the news of a 7-year old boy who was suffering from a severe adenovirus infection and whose family fought hard for access to a drug still being studied in clinical trials, but which presented one of the only hopes for successful treatment. After the manufacturer of the experimental drug denied the request for access to the drug by the boy’s family, a major social media campaign ensued which mounted significant public pressure on the drug company and resulted in a reversal of the decision. The drug company worked with the US Food and Drug Administration (FDA) to grant access to the drug for the boy and other patients like him.
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What You Need to Know to Keep Your Company’s Promotions Out of the Enforcement Spotlight


If you work in the pharmaceutical industry, you know that compliance with FDA rules on promotion is crucial to keeping your business in business. A mere allegation of non-compliance from FDA can have a profound impact on business, both directly (e.g., leading to a drop in sales or stock price) and indirectly (e.g., diverting precious resources to work on a response to the letter). In this article we explore recent FDA enforcement trends related to promotion of pharmaceutical products, and discuss the actions you can take to keep your promotion from getting your company the wrong kind of attention.
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The Compliance and Innovation Balancing Act in Pharma and Biotech


The myriad of challenges pharmaceutical and biotechnology companies face today include striking a balance between innovation and compliance. Companies must innovate in order to remain competitive, yet remain in compliance with the laws, rules and guidance enforced by multiple agencies that may have differing regulatory goals. While the average patient may believe that drug product innovation is limited only by the intellect and imagination of scientists, the unfortunate reality is that innovation is greatly limited by compliance requirements. Among the challenges the industry faces is regulation by the Food and Drug Administration – including both the approval process and Current Good Manufacturing Practice (cGMP) requirements.
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