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

By Winston S. Kirton, Lee H. Rosebush, Lynn Sessions, Laura Macherelli and Marc Wagner on May 15, 2023 Posted in FDA

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 Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH), including its Digital Health Center of Excellence (DHCoE). The paper is neither FDA guidance nor policy but aims to initiate stakeholder feedback and promote subsequent discussions to help inform future regulatory activities.

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

By Amy Fouts and Scott P. Robertson on April 25, 2023 Posted in Post-Dodds

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 approval of the drug in 2000 was arbitrary and capricious. Accordingly, the court stayed the FDA’s 2000 approval of mifepristone and all subsequent challenged actions related to that approval.

Challenge to the FDA’s Approval of Abortion Medication

By Claire Bass and Amy Fouts on April 17, 2023 Posted in Post-Dodds, Post-Roe

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 decision enjoins the FDA from altering the status quo related to mifepristone. The discrepancy is likely to escalate to the Supreme Court of the United States for review.

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Cybersecurity in Medical Devices

By Lee H. Rosebush, Lynn Sessions, Laura Macherelli and Eric Morris on April 10, 2023 Posted in Alert

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 Under Section 524B of the FD&C Act,” stresses the critical need for manufacturers to address cybersecurity risks in medical devices and ensure devices are secure before they can be approved for use.

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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 and Lee H. Rosebush on April 6, 2023 Posted in Podcast

inset glass medicine cabinet in bathroom with door slightly ajar

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 for avoiding common compliance issues discovered during FDA inspections and explore the upcoming implementation of the DSCSA and its impact on supply chain stakeholders. From new technologies to processes for product tracing and verification, we’ll cover the strategies you need to prepare for this important legislation. Additionally, we’ll discuss the importance of being prepared for supply chain disruptions and how onshoring and near-shoring may provide solutions.

Listen now.

FDA Announces Impact of Ending COVID-19 Public Health Emergency

By Winston S. Kirton, Lee H. Rosebush, Francis Palumbo, Laura Macherelli and Marc Wagner on March 16, 2023 Posted in Alert

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 to end the PHE phase of the pandemic response on May 11.

Of the 72 COVID-19-related guidance documents, 22 will no longer be in effect when the PHE declaration expires, 22 will be revised to continue in effect for 180 days after the expiration, 24 will be retained with revisions after the 180 days, and four will remain in effect after the declaration expires.

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

By Laura Macherelli, Daniel Kaufman and Marc Wagner on March 13, 2023 Posted in 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 allow users to search for information on ingredients in dietary supplements and quickly find links to agency actions and communications. Concurrently, FDA is retiring the existing “FDA Dietary Supplement Ingredient Advisory List.”

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

By Lee H. Rosebush, Lance L. Shea and Laura Macherelli on March 6, 2023 Posted in FDA

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 September 2022 to analyze the entirety of the Tobacco Program’s operations. The final report contained 15 recommendations stretching across all areas and aimed at strengthening the program by improving communication, transparency and efficiency.

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FDA Issues Guidance on Clinical Research with Cannabis

By Lee H. Rosebush, Randal M. Shaheen, Winston S. Kirton and Laura Macherelli on January 27, 2023 Posted in Alert

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 Bill, which legalized the production and sale of hemp (cannabis below 0.3 percent delta-9 THC by dry weight) and removed it from the Schedule I substance list.

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FDA Approves Abortion Pill for Sale by Retail Pharmacies

By Amy Fouts and Claire Bass on January 13, 2023 Posted in Alert

Pharmacist and customer discussing prescription in pharmacy

On Jan. 3, the Food and Drug Administration (FDA) finalized a rule allowing more retail pharmacies to dispense abortion pills upon completion of a certification process. The FDA finalized the changes after reviewing supplemental applications from manufacturers of the drug mifepristone requesting modification of the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program.

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