Orphan Drug Exclusivity Recent Developments

Learn about considerations for clinical trial sponsors seeking approval of orphan drugs in light of the exclusivity provisions of the Orphan Drug Act and tension between the interpretation of those provisions by the FDA and the courts.

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Practical Guidance Updates
Featuring the latest updates from your Practical Guidance account.

• The Practical Guidance Journal Second Edition 2023 includes legal developments on generative AI, bank failure impacts, and the risks created by crypto-assets.
• Interested in private Life Sciences data? Attorneys involved in negotiating clinical trial agreements are encouraged to participate in the Private Market Data Life Sciences Survey. Qualified participants will receive a $25 gift card.*
• Legal Developments provide the latest updates and analyses of emerging topics impacting your practice area. Visit the Legal Developments page to see the latest topics, which also include breaking legal news and related Practical Guidance content. 
• Listen Up! The Practical Guidance and Law360 Podcasts Resource Kit features interviews with industry-leading attorneys on cutting edge issues in the law: NFTs, Cannabis, COVID-19, and more.
• Check out the new Practical Guidance Author Center! Learn about the 1750+ leading attorney authors contributing to our 24 practice areas, and find out how you can Become a Practical Guidance Author. Practical Guidance is committed to amplifying diverse voices of attorneys across all differences, including gender and race.

*Offer is void where prohibited by law or by your employer’s policies. Individual must complete the survey in its entirety and in accordance with all instructions by September 30, 2023, to be eligible for gift card offer. Only one gift card, valued at $25, will be given per individual, while supplies last. Employees of any governmental entity are not eligible to participate in this offer. No returns or exchanges. Offer is valid through September 30, 2023. The questionnaire responses will be reviewed for accuracy and relevancy prior to delivery of the gift card. Other restrictions may apply.

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