Article
Would Exercising March-in Rights Lower Biologic Prices?
The Bayh-Dole Act provides that the federal government retains certain rights in inventions it funds.
Goodwin Procter LLP
Worldwide: Food, Drugs, Healthcare, Life Sciences
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HHS Updates The Security Risk Assessment Tool For Small And Medium Group Practices To Assist With HIPAA Compliance
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The "Lead Compound" Approach To Obviousness And Obviousness-Type Double Patenting
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Would Exercising March-in Rights Lower Biologic Prices?
The Bayh-Dole Act provides that the federal government retains certain rights in inventions it funds.
Goodwin Procter LLP
Article
FDA On The Offense! Targeting Pharmaceutical Company Drug Advertising In Wave Of Enforcement Actions
On September 9, 2025, the U.S. Department of Health & Human Services (HHS) and the U.S. Food & Drug Administration (FDA) issued thousands of letters...
Foley & Lardner
Article
FDA Makes Good On Promise To Publish CRLs For Unapproved Drugs And Biologics
On September 4, 2025, the U.S. Food and Drug Administration ("FDA") announced plans to begin releasing complete response letters ("CRLs") "promptly" after it issues them to sponsors...
Ropes & Gray LLP
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FDA Launches Crackdown On Deceptive Drug Advertising And Initiates Rulemaking
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Ninth Circuit: "Snappy" Opioid Slogan Not Deceptive Where Additional Disclosures Clarified Its Context
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Would Exercising March-in Rights Lower Biologic Prices?
The Bayh-Dole Act provides that the federal government retains certain rights in inventions it funds.
Goodwin Procter LLP
Article
HHS Updates The Security Risk Assessment Tool For Small And Medium Group Practices To Assist With HIPAA Compliance
On September 9, 2025, the US Department of Health and Human Services released a new version of the Security Risk Assessment Tool ("SRAT") to assist solo practitioners...
Butzel Long
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FDA On The Offense! Targeting Pharmaceutical Company Drug Advertising In Wave Of Enforcement Actions
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Ninth Circuit: "Snappy" Opioid Slogan Not Deceptive Where Additional Disclosures Clarified Its Context
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