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Allison Fulton is a partner in the Life Sciences and FDA team and is based in the firm's Washington, D.C. office.

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 The final guidance, issued over three years after the draft guidance, provides FDA’s expectations for the content and format of IFUs so that they are consistent across drug and biological products. The FDA’s final guidance does not modify its draft guidance in any major substantive way.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)

The metaverse has been described as the “next frontier” and the “new era” of healthcare. Although still a loosely defined and relatively broad term, the “metaverse” generally refers to a shared virtual environment accessed by individuals via the Internet. Individuals generally enter the metaverse through the following four technologies: virtual reality, augmented reality, mixed reality and extended reality.  

Continue Reading Digital Health in the Metaverse: Three Legal Considerations

The US Food and Drug Administration (FDA) Office of Pharmaceutical Quality (OPQ) of the Center for Drug Evaluation and Research (CDER) recently published a White Paper laying out a framework to evaluate the Quality Management Maturity (QMM) of pharmaceutical manufacturing sites. The White Paper supports CDER’s long-held vision for pharmaceutical quality in the 21st century, described as a “maximally efficient, agile, flexible manufacturing sector” that is able to reliably produce high-quality drug products without extensive regulatory oversight.[1] The Agency is hosting a two-day workshop on May 24 and 25 for stakeholders to provide feedback on the proposed QMM, which may be a welcome shift towards a more holistic, metric-based review of manufacturers with mature quality systems.

Continue Reading FDA White Paper Signals Shift to Performance-Based Reviews of Mature Quality Systems

On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies during the COVID-19 pandemic. Acknowledging that the COVID-19 emergency will not last forever, the FDA’s recent draft guidances propose a 180-day transition path back to “normal operations,” i.e., compliance with the Federal Food, Drug, and Cosmetic Act (FDCA) and regulatory requirements. The transition periods, which would begin (in most cases) 180 days after the end of the public health emergency (PHE), would allow manufacturers, healthcare facilities, and other stakeholders to avoid supply disruptions and product shortages. Following the transition period, manufacturers who want to continue selling covered devices would be expected to comply with all the usual regulatory requirements. Manufacturers who do not wish to continue distribution post-PHE could keep business as usual through the end of the 180-day transition period. Comments on the draft guidance are due on March 23, 2022.  The guidance for EUA devices can be found here, and for devices marketed under COVID-19 enforcement policies, here.
Continue Reading FDA Releases Guidances on Transition Plan for Devices Distributed Under Emergency Use Authorization (EUA) or Enforcement Policies During COVID-19

On December 22, 2021, the Food and Drug Administration (FDA) issued a draft guidance for sponsors, investigators, and other interested parties on using digital health technologies (DHT) to acquire data remotely from participants in clinical investigations. DHTs (such as wearables and sensors) are playing a growing role in clinical research, accelerated by the need for decentralized clinical trials and remote patient monitoring during the COVID-19 pandemic. Though largely directed to study sponsors using DHTs, the guidance raises issues that developers and manufacturers of these technologies will want to be mindful of given the ways in which their products might be used in a broader clinical use case than originally anticipated. Comments on the draft guidance are due March 23, 2022. The full text of the guidance can be accessed here.
Continue Reading FDA Releases Guidance for Digital Health Tech Used in Clinical Investigations

On May 5, 2021, the U.S. Food and Drug Administration (FDA) issued a much-anticipated report, “Resiliency Roadmap for FDA Inspectional Oversight,” which provides a roadmap for the agency’s post-pandemic plans to return to a consistent state of inspection operations.  For the near term, FDA reports that it will continue to prioritize critical inspections of both domestic and foreign facilities, including preapproval inspections for priority products and inspections in reaction to recalls or other safety issues.  For the long term, the agency likely will employ the remote monitoring strategies it has implemented during the pandemic and expand its remote data collection capabilities to preserve resources and curb in-person inspections.
Continue Reading FDA Proposes Risk-Based and Remote Inspection Strategies in New Report

On Wednesday, April 14, 2021, the US Food and Drug Administration (FDA) published a long-awaited final guidance document explaining its policy for conducting remote “evaluations” during COVID-19.  According to the guidance, FDA will request and conduct voluntary remote evaluations at (1) facilities where drugs and biologics are manufactured, processed, packed, or held; (2) facilities covered under the bioresearch monitoring (BIMO) program; and (3) outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA).  The evaluations do not replace in-person inspections, and FDA Form 483s will not be issued as a result of the inspection, but the results could be used to support regulatory actions, such as approving a pending product application. 
Continue Reading Breaking Down FDA’s New Remote Monitoring Strategy

Utah recently signed into law SB 227, creating the Genetic Information Privacy Act (GIPA). The law, which is anticipated to go into effect in May 2021, is aimed at protecting genetic data collected from direct-to-consumer (DTC) genetic testing companies. Companies distributing DTC tests should evaluate their current data privacy policies and practices against the obligations the new Utah law imposes on data use and protection, including user consent, data security, and access and deletion rights, to ensure they are in a position to comply with the new law.
Continue Reading New State Genetic Privacy Law Directed at Consumer Genetic Tests

On Friday, March 26, 2021, FDA published a Federal Register notice,  “Fee rates under the Over-The-Counter Monograph Drug User Fee Program for Fiscal Year 2021,” announcing 2021 fee rates under its over-the-counter (OTC) monograph drug user program.  This is the first year that FDA has collected user fees from OTC drug manufacturers and submitters of OTC monograph order requests under its new authority under the Coronavirus Aid, Relief, and Economic Security (CARES) Act.  With limited exceptions, all manufacturers of OTC drugs must pay a facility fee, which exceeds $20,000, by May 10, 2021 (45 days after publication of the notice).
Continue Reading FDA Announces Facility Fees for OTC Drug Manufacturers