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Jul 23, 2024 | 
jdsupra.com | Patrick Brennan |Bryant M. Godfrey |Tina Papagiannopoulos
Key Takeaways: The Supreme Court’s recent decision striking down the decades-old Chevron1 doctrine in Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Department of Commerce (“Loper Bright”)2 will have significant implications on how the Food and Drug Administration (FDA) operates going forward and the ability of regulated industry to challenge FDA decision-making.
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Jul 15, 2024 | 
jdsupra.com | Regina DeSantis |Bryant M. Godfrey |Tina Papagiannopoulos
Key Takeaways: FDA released a Revised Draft Guidance document with recommended practices for combatting misinformation online. Firms may wish to issue tailored responsive communications to combat specific instances of internet-based misinformation as defined by FDA. FDA establishes an enforcement policy regarding tailored responsive communications which must fall within an outlined scope and include certain disclosures and disclaimers.
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Feb 16, 2024 | 
mondaq.com | Bryant M. Godfrey |Tina Papagiannopoulos
The Food and Drug Administration (FDA) issued a Final Rule to amend device current good
manufacturing practices (CGMP) requirements of the Quality System
(QS) regulation to harmonize the requirements with the
International Organization of Standardization (ISO).
The Final Rule incorporates ISO 13485:2016 by reference.
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Feb 8, 2024 | 
jdsupra.com | Bryant M. Godfrey |Tina Papagiannopoulos
Key Takeaways: The Food and Drug Administration (FDA) issued a Final Rule to amend device current good manufacturing practices (CGMP) requirements of the Quality System (QS) regulation to harmonize the requirements with the International Organization of Standardization (ISO). The Final Rule incorporates ISO 13485:2016 by reference.
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Jan 3, 2024 | 
jdsupra.com | Patrick Brennan |Bryant M. Godfrey
Key Takeaways FDA issued a new Q&A Guidance, which provides helpful context and examples for compliance with its November Direct-to-Consumer Clear, Conspicuous, and Neutral (CCN) Final Rule. The Final Rule provides standards for ensuring that a television or radio commercial for a prescription drug presents its “major statement” on side effects and contraindications in a clear, conspicuous, and neutral manner.
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Nov 1, 2023 | 
lexblog.com | Bryant M. Godfrey
Key Takeaways:This executive order (EO) directs federal agencies to review and develop policies to guide the use of artificial intelligence that touches every sector of the economy. The EO directs the Department of Health and Human Services (HHS) to establish an HHS AI Task Force to develop a strategic plan on the responsible deployment of AI and AI-enabled technologies in healthcare settings.
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Oct 25, 2023 | 
jdsupra.com | Patrick Brennan |Bryant M. Godfrey
Key Takeaways: On October 23, 2023, the Food and Drug Administration (FDA) published a draft guidance, Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products, Questions and Answers. This draft guidance, if finalized, will supersede FDA’s 2014 draft guidance document, Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices.
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Oct 3, 2023 | 
jdsupra.com | Bryant M. Godfrey |Tina Papagiannopoulos
Key Takeaways: The Food and Drug Administration’s (FDA) proposed rule would change decades of Laboratory Developed Test (LDT) regulation by expressly considering these in vitro diagnostics (IVDs) medical devices. LDT companies would need to comply with medical device statutes and regulations including submission requirements, manufacturing standards, and user fees. FDA plans to phase out its LDT enforcement in stages beginning in 2024 and ending in 2028.
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Sep 26, 2023 | 
jdsupra.com | Bryant M. Godfrey |Tina Papagiannopoulos
Key Takeaways: FDA’s recent draft guidance, Regulatory Considerations for Prescription Drug Use Related Software, proposes a regulatory framework for software disseminated by a drug sponsor that supplements or relates to a prescription drug product. Prescription Drug Use Related Software (PDURS) may be regulated as a component of a drug’s labeling, as a device, or as a component of a combination product depending on the drug and on the software’s functionality.
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Sep 1, 2023 | 
jdsupra.com | Jesse Alderman |Bryant M. Godfrey |Tina Papagiannopoulos
In light of the August 30, 2023 historic recommendation from the U.S. Department of Health and Human Services (HHS) to reschedule cannabis to Schedule III, a multidisciplinary group of attorneys from Foley Hoag’s nationwide Cannabis practice provides the following outlook and analysis of what’s next:Rescheduling Q&A1) What happened?
