Expertise in all things FDA
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 …
March 20, 2024 Hyman, Phelps & McNamara, P.C. (HP&M), the largest dedicated food and drug law firm in the U.S., is pleased to announce that Director Allyson Mullen has been appointed to the Board of Directors of the Association of Medical Diagnostic Manufacturers (AMDM). This prestigious appointment recognizes Ms. Mullen’s …
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 …
WASHINGTON, DC — Hyman, Phelps & McNamara, P.C. is pleased to announce it took top honors in two categories in the 2023 LMG Life Sciences Awards, which recognize the best life science practitioners and firms over the past 12 months from the United States, Canada, …
October 11, 2023 Hyman, Phelps & McNamara, P.C. (“HP&M”), the largest FDA-dedicated law firm, is pleased to announce that Julie Beitz, M.D. has joined the firm as a Principal Drug Regulatory Expert. Dr. Beitz served in leadership positions in FDA’s Center for Drug Evaluation and Research for …
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 …
Hyman, Phelps & McNamara P.C. (HP&M), a leader in providing legal and regulatory support to the life sciences industries, today announced the appointment of Jeff Grizzel to the newly created position of Chief Marketing Officer (CMO). Grizzel will oversee the marketing organization, with responsibility for …
August 25, 2023 Hyman, Phelps & McNamara, P.C. (“HP&M”) is is proud to announce that 14 of the Firm’s attorneys have been selected to the 2024 edition of The Best Lawyers in America®. Newly recognized this year are attorneys Josephine M. Torrente (FDA Law), Michelle L. Butler (FDA Law), Sara W. …
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 …
April 4, 2022 With great sadness, we announce that our firm’s co-founder, leader, colleague and friend, Jim Phelps passed away on April 2, 2022, at the age of 83. Jim is survived by Sophia, his wife of 57 years, his three sons and their wives, Evan …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased and excited to announce that Dr. Ellis F. Unger has joined the firm as a Principal Drug Regulatory Expert. Dr. Unger is a cardiologist and former Director of the Office of Drug Evaluation-I in FDA’s Office of …
January 6, 2022 Hyman, Phelps & McNamara, P.C. (HP&M) is pleased to announce Adrienne R. Lenz has become its first Principal Medical Device Regulation Expert. Adrienne joined HPM in September 2017. In her time with HPM, she has made significant contributions to the firm and its clients. Prior …
January 6, 2022 Hyman, Phelps & McNamara, P.C. (HP&M) is pleased to announce that Sara W. Koblitz has become the firm’s newest Director. Sara’s practice covers the intersection of FDA regulatory issues and Intellectual Property, including the Hatch-Waxman Amendments, the Biologics Price Competition and Innovation Act, and the …
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 …
Hyman Phelps & McNamara, P.C. is pleased to announce that Sara Koblitz has been promoted to Counsel at the firm. Sara joined HPM in 2017 and advises clients on a broad range of FDA regulatory issues with a particular focus on Hatch-Waxman patent and exclusivity, biosimilars, and the …
Hyman, Phelps & McNamara, P.C. (“HP&M”) has been named the FDA Law “Law Firm of the Year” by the folks over at U.S. News & World Report, who teamed up with Best Lawyers for the 2021 “Best Law Firms” rankings. We’re truly honored! But the honors …
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 …