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Health Law Update

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By: Baker & Hostetler LLP

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Latest from Health Law Update

Health Law Update

FDA Clarifies Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act

By Lee H. Rosebush, Laura Macherelli & Marc Wagner
June 28, 2023
FDA wrote with wooden blocks
FDA - Food and Drug Administration wrote with wooden blocks, casting a beautiful shadow on white surface.

On June 27 the Food and Drug Administration (FDA) published Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry. In this draft guidance, the FDA provides examples of activities prohibited…

Health Law Update

Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products

By Winston S. Kirton, Lee H. Rosebush, Lynn Sessions, Laura Macherelli & Marc Wagner
May 15, 2023
Woman and heart hologram
A young woman's right hand showing human heart hologram.

On May 10, the U.S. Food and Drug Administration (FDA) published a discussion paper, “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products.” The paper is a collaboration between FDA’s Center for Drug…

Health Law Update

Supreme Court Orders That Mifepristone Remain Widely Available Pending Appeal in Fifth Circuit

By Amy Fouts & Scott P. Robertson
April 25, 2023
Supreme Court building, Washington, DC

On Friday, April 7, the Northern District of Texas issued a decision blocking the prescribing and dispensing of mifepristone nationwide. The court held that plaintiffs had a substantial likelihood of success on the merits regarding their arguments that the FDA…

Health Law Update

Challenge to the FDA’s Approval of Abortion Medication

By Claire Bass & Amy Fouts
April 17, 2023
Abortion drug pills and drinking water
Birth control abortion drug, morning after pill

On Friday, April 7, both the Northern District of Texas and the Eastern District of Washington issued decisions impacting the FDA approval of the abortion drug mifepristone. The Texas decision blocks prescribing and dispensing of mifespristone nationwide, while the Washington…

Health Law Update

​​​​​​​Cybersecurity in Medical Devices

By Lee H. Rosebush, Lynn Sessions, Laura Macherelli, Eric Morris & Rita Hechmer
April 10, 2023
smart doctor
Modern VR with medical technology diagram concept.smart doctor showing 3d globe in front view on dark background.

The U.S. Food and Drug Administration (FDA) has issued new guidance to the medical device industry on the importance of cybersecurity measures in product development. The nonbinding guidance, titled “Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices…

Health Law Update

Staying Ahead of the Curve in Biopharma: Navigating FDA Inspections, Drug Supply Chain Security Act (DSCSA) Implementation, and Supply Chain Disruptions

By Winston S. Kirton & Lee H. Rosebush
April 6, 2023
inset glass medicine cabinet in bathroom with door slightly ajar
glass medicine cabinet with bottle of medicine partially showing

FDA inspections of biopharmaceutical manufacturers often lead to the discovery of avoidable compliance issues.

On today’s episode, Staying Ahead of the Curve in BioPharma: Navigating FDA Inspections, Drug Supply Chain Security Act (DSCSA) Implementation, and Supply Chain Disruptions, we discuss tips…

Health Law Update

FDA Announces Impact of Ending COVID-19 Public Health Emergency

By Winston S. Kirton, Lee H. Rosebush, Francis Palumbo, Laura Macherelli & Marc Wagner
March 16, 2023
Front Line Worker Holding Syringe and Vial Filled with Coronavirus Vaccine or Medicine Silhouetted Against American Flag
Front Line Worker Holding Syringe and Vial Filled with Coronavirus Vaccine or Medicine Silhouetted Against American Flag.

On March 13 the FDA officially issued a Federal Register notice to explain how the end of the COVID-19 PHE declaration will impact the Agency’s 72 COVID-related guidance documents currently in effect. The notice comes as the Biden administration plans…

Health Law Update

FDA Launches New Directory of Ingredients Used in Products Marketed as Dietary Supplements

By Laura Macherelli, Daniel Kaufman, Marc Wagner & Scott Danielson
March 13, 2023
FDA

On March 6, the FDA announced the launch of its new “Dietary Supplement Ingredient Directory.” According to the FDA, the directory is “a one-stop shop of ingredient information that was previously found on different FDA webpages.” It will…

Health Law Update

FDA’s Center for Tobacco Products Announces Next Steps to Strengthen Tobacco Program

By Lee H. Rosebush, Lance L. Shea & Laura Macherelli
March 6, 2023
FDA wrote with wooden blocks
FDA - Food and Drug Administration wrote with wooden blocks, casting a beautiful shadow on white surface.

FDA Commissioner Robert M. Califf, MD, MACC, released a statement on Feb. 24, 2023, announcing next steps the FDA’s CTP plans to take in response to an external evaluation conducted by the Reagan-Udall Foundation. Califf commissioned the external evaluation in…

Health Law Update

FDA Issues Guidance on Clinical Research with Cannabis

By Lee H. Rosebush, Randal M. Shaheen, Winston S. Kirton & Laura Macherelli
January 27, 2023
close up of a cannabis oil capsule composit image as a product concept

On Jan. 23, the Food and Drug Administration (FDA) finalized industry guidance for clinical research using cannabis and cannabis-derived compounds, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. The need for the guidance stemmed from the 2018 Farm…

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