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Audrey Crowell

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Audrey Crowell is an associate in the Corporate Practice Group in the firm's Dallas office and a member of the Healthcare, FDA and Life Sciences teams.

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On June 21, 2023, the U.S. Food and Drug Administration (“FDA”) issued a warning letter to Zyto Technologies, Inc. (“Zyto”), citing Zyto’s promotion of its Hand Cradle Galvanic Skin Response (“GSR”) device and associated software for uses outside the scope of the device’s 510(k) clearance.[1] This warning letter is one of only a handful issued this year to medical-device manufacturers, and comes shortly after FDA issued a warning letter to iRhythm Technologies, which we wrote about, for touting uses for a remote monitoring device which were, in FDA’s opinion, outside the scope of the product’s 510(k) clearance.[2] These enforcement actions indicate that FDA is keeping a close eye on the promotion of software-enabled medical devices, especially when that promotion suggests a function that has not been approved and/or cleared by FDA for the device.…

Continue Reading FDA Maintains Focus on “Intended Use” for Software-Enabled Medical Devices

On May 17, the U.S. Food & Drug Administration (“FDA”) issued two important draft guidance documents, which clarify the agency’s approach to requirements and incentives in the realm of pediatric drug development — “Regulatory Considerations Guidance”[1] and “Scientific Considerations Guidance,”[2] respectively. These guidance documents replace FDA’s previous draft guidance on the subject,[3] issued in 2005, and clarify requirements and recommendations for brining pediatric drugs to market. FDA will be accepting public comment on the Regulatory Considerations Guidance and Scientific Considerations Guidance through July 17 of this year.[4]…

Continue Reading FDA Clarifies Approach to Pediatric Drug Development

On April 5, 2023, the U.S. Food and Drug Administration (“FDA”) announced its decision to withdraw the approval of Makena® hydroxyprogesterone caproate injection (“Makena”) – a drug that was approved in 2011 to reduce the risk of preterm birth in certain pregnant women.[1] The final decision followed a hearing and appeal process that took nearly three years, and cited the failure of post-approval studies to prove the drug’s effectiveness as the reason for the withdrawal.[2] …

Continue Reading Withdrawal of Drug Approval Highlights Risk of Accelerated Approval Pathway

On March 29, 2023, and March 30, 2023, the U.S. Food & Drug Administration (“FDA”) issued a series of FAQs[1] and a guidance document[2] clarifying the agency’s intended implementation of the Consolidated Appropriations Act of 2023 (the “Omnibus”), which amended Section 524B of the Food, Drug & Cosmetics Act (the “FD&C Act”) to require the demonstration of cybersecurity safeguards in pre-market submissions for certain medical devices.[3] …

Continue Reading FDA To Require Demonstration of Cybersecurity Safeguards for Pre-Market Submissions of Certain Medical Devices

The Sheppard Mullin Life Sciences Team decided to take a different approach to our year-end review. We surveyed and considered issues most important to our clients, asking the experts across the various specialties in our Life Sciences Practice the following question: What do life sciences companies need to keep top of mind in 2023?…

Continue Reading 2023 Top-of-Mind Issues for Life Sciences Companies

On December 15, the U.S. Food and Drug Administration (FDA) issued a draft guidance, titled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection” (the “Inspection Draft Guidance”), which clarifies the types of behaviors that FDA considers to be inappropriately delaying, denying, limiting, or refusing access to an inspection, each of which constitutes adulteration of a drug or device under the Federal Food, Drug, and Cosmetic Act (FDCA).[1] The Inspection Draft Guidance clarifies certain behaviors described in FDA’s previous guidance on the subject (the “2014 Guidance”) and, most significantly, expands the previous guidance to apply to medical device manufacturers.…

Continue Reading FDA Expands Inspection Guidance to Apply to Device Manufacturers

As we take a breather during the holiday whirlwind, we wanted to flag for readers a recent development in advertising and promotion regulation that FDA quietly released nearly a month ago. In a Memorandum issued on October 27 (the “Memorandum”), the Food and Drug Administration (“FDA” or the “Agency”) indicated that it will now permit certain COVID-19 drugs that have been granted Emergency Use Authorization (“EUA”) to make claims of safety and efficacy in print, advertising, and promotional materials, pursuant to certain limitations.…

Continue Reading FDA Lightens Promotional Restrictions for Certain COVID-19 Drugs with Emergency Use Authorization

On October 5, 2022, the Office of Inspector General (“OIG”) posted Advisory Opinion No. 22-19 (the “Opinion”), which limits the ability of pharmaceutical manufacturers to offer cost-sharing subsidies to Medicare Part D (“Part D”) beneficiaries via 501(c)(3) charities without running afoul of the Federal Anti-Kickback Statute (the “AKS”).…

Continue Reading OIG Limits Pharmaceutical Manufacturers’ Ability to Offer Drug Cost-Sharing Subsidies

With a September 24, 2022 compliance date looming, the U.S. Food and Drug Administration (FDA) announced that will delay enforcement of its requirement to submit Unique Device Identifier (UDI) data for low-risk consumer health products. Consumer health products, as described in the FDA guidance, include class 1 devices that are typically sold directly to consumers, such as digital health products and consumables. The FDA guidance extends the compliance date for data submission from September 24, 2022 to December 8, 2022, giving manufacturers of consumer health products more time to prepare their submissions.…

Continue Reading FDA Delays Enforcement of UDI Reporting Requirements for Consumer Health Products

On July 15, 2022, the Food and Drug Administration (FDA) issued its final guidance on developing the content and format of patient Instructions for Use (IFU) for human prescription drug and biological products, as well as drug-led or biologic-led combination products submitted under a new drug application (NDA) or a biologics license application (BLA). The final guidance, issued over three years after the draft guidance, provides FDA’s expectations for the content and format of IFUs so that they are consistent across drug and biological products. The FDA’s final guidance does not modify its draft guidance in any major substantive way. Rather, as stated by the FDA, the final guidance merely includes “editorial changes to improve clarity.”…

Continue Reading FDA Issues Final Guidance on Drug and Biological Instructions for Use (IFU)