Publications

The recent issuance of FDA’s draft guidance, Deciding When to Submit a 510(k) for a Change to an Existing Device, which, when finalized, will replace the guidance of the same name issued in January 1997, was undoubtedly met with both excitement and trepidation for companies …

Ricardo Carvajal & Jay Cormier published an article in the JULY/AUGUST 2016 FDLI Update magazine on CRISPR and Gene Editing.

Next generation sequencing (NGS) is playing an increasingly important role in clinical research and clinical diagnostics. This expanding utilization has largely occurred outside of the U.S. Food and Drug Administration’s (FDA’s) regulatory process. In part, this is due to the lack of clear regulatory guidance …

On March 2, 2015, investigators from the U.S. Food and Drug Administration walked into a factory at Zhejiang Hisun Pharmaceutical in China to conduct an inspection. According to the investigators, at one point a lab employee pulled a memory stick from a computer and put …

This year marks the 40th anniversary of the Medical Device Amendments. Some might think that the MDA’s ruby anniversary would be celebrated by stability, predictability, and a general easing of regulatory developments and challenges. Thanks to technological developments in digital health, laboratory testing (e.g., genetic …

For years, the government has threatened to increase the number of criminal charges it brings against executives of companies that have violated the Federal Food, Drug, and Cosmetic Act (“FDC Act”), even in the absence of intent or even knowledge of the company’s wrongdoing. The …

The Department of Justice’s (DOJ) recent criminal prosecution of Vascular Solutions, Inc. (VSI) ended in a spectacular loss for the government. The defense rested without calling even a single witness, but the jury unanimously acquitted VSI and its chief executive officer of, among other things, …

Co-authors of sections on U.S. Regulatory Requirements Edited by Duncan Bucknell Additional information available here.

In the emerging world of regenerative medicine, there is a stark dichotomy in the level of regulation applied to products derived from human cells and tissues, or what FDA calls “human cells, tissue or cellular and tissue-based products” (HCT/Ps).

In the Federal Register of August 28, 2015, the Health Resources and Services Administration (“HRSA”) of the Department of Health and Human Services (“HHS”) published an omnibus guidance document to implement the 340B Drug Discount Program (the “Proposed Guidance”). This program, which was established in 1992 pursuant to …

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The Federal Controlled Substances Act (CSA) and regulations promulgated by the Drug Enforcement Administration (DEA) provide for the adjudication of administrative actions involving entities registered to handle controlled substances. DEA annually adjudicates dozens of matters, the majority of which involve determining whether a party should be …

Thomson Reuters Book: Commercialisation of Health Care, Second Edition, October 2015 Additional information available here.

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Sasinowski, F., Panico, E. & Valentine, J., “Quantum of Effectiveness Evidence in FDA’s Approval of Orphan Drugs: Update, July 2010 to June 2014, Therapeutic Innovation & Regulatory Science, vol. 49(5), 680-697 (2015). The Drug Information Association journal, Therapeutic Innovation and Regulatory Science, published the findings of …

David Clissold and James Valentine* co-authored Chapter 3-1, “FDA Regulatory Scheme” and Alexander Varond authored Chapter 3-7, “Orphan Drugs” in the Food and Drug Law Institute’s guidebook Bringing Your Pharmaceutical Drug to Market. Both chapters cover essential elements of development and approval of pharmaceutical products in …

In this Legal Backgrounder published by the Washington Legal Foundation, HPM authors write a “Warning Letter” to FDA-regulated drug establishments regarding FDA’s inspection practices. This article addresses several of the unresolved questions regarding FDA’s inspection authority and aggressive inspection practices, as discussed in FDA’s …

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An interview with Frank Sasinowski was published in a Neurological Rare Disease Special Report, a Supplement to Neurology Reviews. In the interview, Mr. Sasinowski discusses how FDA has consistently exercised reasonable, appropriate, science-based flexibility in its review and approval of rare disease therapies. If you have …

The majority of new medical devices reviewed by FDA enter the market via the 510(k) process. In 2013, FDA cleared approximately 140 510(k)s for every original PMA application approved. For most medical device companies, it is critical to understand the 510(k) process, evaluate the likelihood of …

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On July 31, the Food and Drug Administration (FDA) notified Congress that it intended to issue two draft guidances regulating laboratory-developed tests (LDTs). While the Energy & Commerce Committee House Subcommittee on Health did hold a hearing on September 9, Congress took no steps to …

The Millennium Development Goals (MDGs) have been criticised for being created by developed countries for developing ones. For its post-2015 Sustainable Development Goals (SDGs), the UN Development Group (UNDG) undertook 88 national consultations to “widen the net of engagement” and include the views of vulnerable …

For decades, FDA has asserted that it has the authority to regulate laboratory-developed tests (LDTs). But on July 31, 2014, FDA took its biggest steps yet toward actively regulating such tests: FDA notified Congress of its intent to issue two draft guidance documents regarding oversight …

Jeff Gibbs authored and article “FDA Announces Intention to Regulate LDTs as Devices” for Genetic Engineering & Biotechnology News In 1992, the Food and Drug Administration (FDA) first stated that it had authority to regulate laboratory-developed tests. On July 31, FDA took its biggest step toward …

Anne Walsh and Jennifer Thomas co-authored Chapter 22, “, Significant Settlements”, of FDLI’s book “Top 20 Food and Drug Cases, 2013 & Cases to Watch, 2014” The chapter provides summary of the top settlements that have occurred in 2013 affecting drugs, biologics, devices, foods and dietary …

In vitro diagnostics (IVD) companies today are facing a number of challenges related to FDA regulation of their products and tests. And many of these challenges can be summed up with just one word: uncertainty. Many regulatory challenges for IVD companies relate to issues that …

Earlier this year, FDA issued the final guidance, “

FDA and LDTs – What’s Next? The Administration is claiming power over laboratory-developed tests. However, the lab industry disagrees. Jeffrey N. Gibbs Additional information available here.

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After months of Congressional consideration throughout the year, on November 27, 2013, President Obama signed into law the “Drug Quality and Security Act” (DQSA). Title I of the DQSA, titled the Compounding Quality Act, both removes the unconstitutional advertising and promotion provisions that for years plagued …

The purpose of this bibliography is to present studies from peer-reviewed and grey literature that used consultations and other participatory strategies to capture a community’s perspective of their health priorities, and of techniques used to elevate participation from the implementation phase to a more upstream …

Hyman, Phelps & McNamara, P.C. has updated the firm’s outline on the Application of the Health Care Fraud and Abuse Laws to the Marketing of Pharmaceuticals and Medical Devices. The outline, which was last updated in 2009, has been expanded to cover devices as …

This book published by Thomson Reuters, delves into how health care products, including drugs, medical devices, biologics, and dietary supplements, are regulated across 21 major jurisdictions throughout the world. Jeff Gibbs is one of the general editors. Jeff Gibbs, Jennifer D. Newberger, and Alexander J. …

This RAPS article discusses the recent trends and developments in personalized medicine, including FDA’s current thinking and new challenges facing industry. Despite the promising potential of personalized medicine, the field is still in its infancy and there is much uncertainty. The article surveys key issues …

Over the years, FDA’s regulation of in vitro diagnostics (lVDs) has raised many policy issues. Some are short-lived and quickly resolved, such as the creation of the Analyte Specific Reagent (ASR) regulation, and the subsequent guidance which curtailed the distribution of ASRs. Other policy issues …

Over the past year, the US Food and Drug Administration (FDA) has steadily acted against medical device manufacturers for off-label promotion. FDA’s enforcement against medical device manufacturers has typically taken the form of Warning Letters. Between 1 May 2012, and 30 April 2013, …