Category Archives: Regulatory Affairs

The Drug Supply Chain Security Act: Current Impact

On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 (DQSA) into law, bringing a successful conclusion to efforts by the industry and consumer groups to create a national pharmaceutical serialization and track and trace regulation under the FDA’s jurisdiction, one that eliminates the patchwork of state laws in…
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Regulatory Challenges of Orphan Drug Development

There are nearly 7,000 diseases that are considered rare in the United States. The majority of these diseases, which collectively affect 25 million Americans, are serious, life-altering, life-threatening, or fatal. A large number also have a genetic component or are the result of infectious agents. There have been several meaningful advances in rare disease product…
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The Role of Statistics in Briefing Books for FDA Meetings

Briefing documents are necessary for achieving productive (and hopefully successful) meetings with the FDA. The FDA describes the materials as the “meeting package”; many companies refer to these materials as the Briefing Package, Briefing Document, or Briefing Book (as often the documents are printed hard-copy, bound, and shipped to the FDA for use by their…
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FDA’s Expedited Development Programs for Compassionate Use

FDA has four programs that are intended to facilitate and expedite development and review of new drugs and biologics that address unmet medical needs in the treatment of serious or life-threatening conditions. Serious conditions include diseases or conditions associated with morbidity that has a substantial impact on day-to-day functioning. The programs are described in FDA’s…
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