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  • Feature ArticlesFeature Articles

    US Orphan Drug Legislation: Current Status and Recent Developments

    This article discusses the impact of recent orphan drug legislation and regulatory developments and covers the Food and Drug Administration Reauthorization Act of 2017 (FDARA), the Orphan Drug Modernization Plan and the 21st Century Cures Act. The authors answer questions regarding what drugs qualify as an orphan drug and how an orphan drug gets approval. Introduction While they have had legal existence for close to 35 years and often served as a regulatory strategy for...
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    FDA Citizen Petitions: What They Can and Cannot Do

    This article provides an overview of the US Food and Drug Administration's (FDA's) citizen petition process as it relates to the drug industry and highlights several key issues raised by this process. The authors focus on 505(q) and discuss its potential implications. Introduction FDA regulations provide for a citizen petition process enabling the public to request FDA to take or refrain from taking a certain action. The citizen petition process also is used to bring ot...
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    Why Respond to an FDA 483 in a Timely Manner

    We reviewed some warning letters issued by the US Food and Drug Administration (FDA) this year that reminded us of the 1981 hit song by Styx, "Too Much Time on My Hands." Two companies had received a FDA 483 List of Observations following an inspection. 1, 2 The companies accordingly responded to the agency within 15 business days; however, they also provided subsequent substantive responses to the FDA 483 outside of the 15-day window. In the warning letters, FDA acknowl...
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    FDA Issues Notices of Violation for Promoting Investigational Products as Safe and Effective

    Despite all of the public discussion about FDA's enforcement approach in the off-label promotional arena, the agency continues to take action against any perceived unlawful promotion. Recently, FDA issued Notice of Violation letters to drug companies for promoting their investigational new drugs as safe and effective. Introduction The US Food and Drug Administration's Office of Prescription Drug Promotion (OPDP) did not take the summer off, despite the uncertainty sur...
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    Do Recent First Amendment Court Developments Deal a Blow to the Government?

    This article discusses the Amarin/FDA court settlement, the verdict in favor of Vascular Solutions and other developments relating to off-label promotional communications. Introduction The US Food and Drug Administration has suffered two widely-publicized setbacks relating to off-label promotion oversight. In both cases—one involving a pharmaceutical company (Amarin) and the other a medical device firm (Vascular Solutions) and its chief executive officer—the governmen...
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    Compliance: Not Just a US Issue

    “Compliance” might be one of the most frequently-used terms in the healthcare industry. Compliance covers so many things and, in fact, is not merely a US issue. Life science companies must ensure global compliance, and this collection of feature articles in Regulatory Focus exclusively for RAPS members only scratches the surface. In “ Regulatory Quality Compliance Programs for Drugs and Biologics in the US and Canada ,” Ryan Thompson, Vadim Lysenko, Mukesh Kumar, Giri ...
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    US Orphan Drug Exclusivity Criteria Clarified in Depomed Court Decision

    A recent US district court decision could affect US Food and Drug Administration (FDA) interpretation and determinations in the orphan drug exclusivity area. Specifically, on 5 September 2014, the United States District Court for the District of Columbia issued its memorandum opinion in the case of Depomed Inc. v. United States HHS . 1 The case centers on the Orphan Drug Act , which provides incentives to pharmaceutical companies to research and develop drugs for rare ...
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    Legal Considerations When Outsourcing: Hold on Loosely, but Don’t Let Go

    In 1981, the US rock band .38 Special sang "Hold on Loosely, But Don't Let Go." This song lyric about love also holds true when considering whether to outsource regulatory responsibilities. Companies can attempt to contractually delegate to third parties, and it might make sense in many cases. However, it is important to recognize that a company regulated by the US Food and Drug Administration (FDA) remains on the hook to comply with the Federal Food, Drug, and Cosmetic...