Publications

Anne Walsh is quoted in this article

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Inspection authority is one of the most valuable tools the FDA has to create its gold-standard culture of safety and efficacy. No drug or device maker is happy to see FDA when they come calling to scrutinize operations, but every consumer of their products demands …

To borrow (at least in part) from Shakespeare, “FDA doth protest too much, methinks” when it comes to its proposed rule that would impose more stringent regulatory controls of wound products. These protestations begin with FDA maintaining that wound products with antimicrobials may contribute to …

For over a decade, the Food and Drug Administration (FDA) has devoted extensive resources to banning the use of an FDA-cleared medical device that is being successfully used by medical doctors and other licensed health care professionals at one facility to treat approximately 50 patients …

Laboratory Developed Tests (LDTs), which are diagnostic tests developed, manufactured, and used within a single laboratory, play an essential role in health care in the United States. For example, LDTs are routinely used in genetic screening of couples considering having a child, prenatal testing of …

The recent settlement agreement between Ron L. Lacks,grandson of Henrietta Lacks and executor of Ms. Lacks’estate, and Thermo Fisher Scientific Inc., one of the largestlife science companies in the world, came about after tissuefrom Ms. Lacks was surgically removed more than 70 years agowithout her …

Large clinical trials provide the opportunity to assess treatment effects in subgroups of patients, based on baseline demographic and disease-related factors, and there is always great interest in these analyses. Generally, the term “pre-specification” has major ramifications for clinical trials, particularly for adequate and well-controlled …

Patient-centered research has emerged as critically important for understanding the impact of treatments on key stakeholders. The subjective experience of quality of life (QOL) is increasingly recognized as fundamental to delineating treatment goals. The present study utilized content analysis of qualitative data and quantitative analysis …

AbstractDuchenne muscular dystrophy (DMD) is a serious, rare genetic disease, affecting primarily boys. It is caused by mutations in the DMD gene and is characterized by progressive muscle degeneration that results in loss of function and early death due to respiratory and/or cardiac failure. Although …

A decade ago, questions still lingered among pharmacies concerning whether FDA had a legal right to conduct an inspection of their facility. After all, Section 704 of the Federal Food, Drug, and Cosmetic Act (FDCA) seems to exclude (at least to a degree) a pharmacy …

After 5 long years, FDA has finally adopted the long-awaitedOTC hearing aid rules. While the Proposed Rule was a year anda half overdue, FDA impressively turned out the Final Rule about7 months after the close of comments on the Proposed Rule, whichis only one month …

Abstract:There are approximately 8,000 recognized rare diseases affecting close to 30 million people in the United States. Sponsors choosing to engage in research and development of drugs for rare diseases, known as orphan drugs, face challenges and opportunities that are unique to orphan drug development. …

The U.S. Food and Drug Administration (FDA) had only exercised its authority to ban medical devices twice by the time it finalized its ban on electrical stimulation devices (ESDs) for patients with self-injurious behavior (SIB) and aggressive behavior (AB). Jeff Gibbs, Faraz Siddiqui and Veronique …

The Food and Drug Administration (FDA) has been privately lobbying Congress to overturn recent judicial decisions that curb the agency’s discretion. While Congress can override federal court decisions, use of that authority to concentrate further power in a single executive-branch agency—and doing so without notice …

On November 15, 2021, the U.S. Department of Health and Human Services (“HHS”) and the Food and DrugAdministration (“FDA”) issued several policy changes governing the regulation of Laboratory Developed Tests(“LDTs”). These changes resume FDA premarket review of COVID-19 LDTs that HHS halted in August 2020 …

Addressing the COVID-19 pandemic has created many challenges for the Food andDrug Administration (FDA). One of the largest challenges in coping with COVID-19has stemmed from the ongoing need for access to accurate diagnostic tests for thevirus. FDA has well-established programs for reviewing in vitro diagnostic …

James Valentine, co-authored this chapter in the book, “Rare Disease Drug Development: Clinical, Scientific, Patient, and Caregiver Perspectives by Raymond Huml (Editor)

Mark is quoted extensively in this article

This study describes the person-centered experience and impact of symptoms and thetreatment needs of dementia-related psychosis (DRP) from a patient and care partner perspective.

Citing agency experience and expertise, courts have long afforded federal agencies discretion in administering their respective statutes.  But, in Genus Med. Techs., LLC v. United States FDA, 2021 U.S. App. LEXIS 10928, 994 F.3d 631 (D.C. Cir. 2021), the U.S. Court of Appeals for the District …

Every year, the Food and Drug Law Institute (FDLI) publishes a compendium of the Top Food and Drug Cases from the previous year, as well as Cases to Watch, in conjunction with its popular Annual Conference.

Every year, the Food and Drug Law Institute (FDLI) publishes a compendium of the Top Food and Drug Cases from the previous year, as well as Cases to Watch, in conjunction with its popular Annual Conference.  In this year’s publication, Sara Koblitz explains an …

Mark Schwartz is quoted in this article

Mark is quoted in this article

More information about book can be found here

The FDA under President Joe Biden has the opportunity to improve the availability of Covid-19 testing. Hyman, Phelps & McNamara P.C. attorneys say the FDA can start by eliminating needless hurdles in the regulatory approval process, providing greater clarity, and applying criteria consistently.

FDA is relying on other global inspection reports and remote document review, yet does not consider them equivalent to on-site inspections. Manufacturers await more clarity. Mark Schwartz is quoted in this article.

Nearly a year into the pandemic, the Food and Drug Administration, unlike its foreign counterparts, has yet to advance alternatives to on-site facility inspections. Mark I. Schwartz, a director at Hyman, Phelps & McNamara P.C. and former deputy director for the FDA’s Office of Compliance and Biologics Quality, says …

For more than twenty years, the U.S. Food and Drug Administration’s (“FDA’s” or “the Agency’s”) position has been that it could regulate a product as either a drug or a medical device as long as the product meets both statutory definitions. The implications of this approach, however, lead …

As the FDA considers regulations for OTC hearing aids, one of the thorniest issues it faces is federal preemption of all the various state laws that help protect consumers – many of which focus on the dispensing professional and not on the actual hearing device.

Pregnancy is a period of significant change that impacts physiological and metabolic status leading to alterations in the disposition of drugs. Uncertainty in drug dosing in pregnancy can lead to suboptimal therapy, which can contribute to disease exacerbation. A few studies show there are increased …

On Aug. 19, the U.S. Department of Health and Human Services published a brief announcement on its website that the U.S. Food and Drug Administration, an agency within HHS, will not require premarket review of laboratory-developed tests, absent notice-and-comment rulemaking. The announcement — published without fanfare on a …

On March 27, President Donald Trump signed into law the Coronavirus Aid, Relief and Economic Security Act, also known as Phase 3 of the coronavirus stimulus legislation. Title III, Subtitle F of the CARES Act, a provision unrelated to the current coronavirus pandemic, is an …

The First International Conference in Systems and Network Medicine gathered together 200 global thought leaders, scientists, clinicians, academicians, industry and government experts, medical and graduate students, postdoctoral scholars and policymakers. Held at Georgetown University Conference Center in Washington D.C. on September 11–13, 2019, the event …

The Q&A gives a high level overview of distribution and marketing of drugs law, including pre-conditions for distribution; licensing; wholesale distribution; marketing to consumers; marketing to professionals and engagement with patient organisations. To compare answers across multiple jurisdictions, visit the Distribution and Marketing of Drugs Country Q&A …

Mark Schwartz is quoted in this article

When does a single positive adequate and well-controlled study of a new drug meet the statutory requirement to demonstrate substantial  evidence of effectiveness? The answer to this question, particularly with respect to new molecular entities, has been of considerable debate since 1962 when the requirement that new …

On September 13, 2019 FDA issued a final guidance document The Special 510(k) Program (“Guidance”). This Guidance, along with The Abbreviated 510(k) Program, supersedes the 1998 guidance document The New 510(k) Paradigm — Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.

In this white paper, experts from the Digital Pathology Association (DPA) define terminology and concepts in the emerging field of computational pathology, with a focus on its application to histology images analyzed together with their associated patient data to extract information. This review offers a historical perspective …