Expertise in all things FDA
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.
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 …
January 17, 2020 Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Gail Javitt has become its newest Director. Many leading companies have turned to Gail for her deep knowledge, skills, experience and thought leadership on the complex regulatory issues they face while looking to innovate …
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.
Awards season is now underway and we are delighted to announce that LMG Life Sciences has named Josephine Torrente the 2019 “Regulatory Attorney of the Year: FDA Pharmaceuticals.” Now in its seventh year, the LMG Life Sciences Awards are presented to the firms and individuals “behind …
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 …
Interest in and use of telemedicine services appears to be dramatically increasing. According to researchers, telehealth visits by members of one private US health plan rose by 52% annually from 2005 to 2014, and soared by 261% from 2015 to 2017. As more people seek to use telemedicine …
FDA advisory panels meetings to review pre-market applications (PMAs) are high-stakes events. While FDA is not bound by the vote of the advisory panel, it has been long-accepted that the agency typically follows the recommendation of the panel. Which got us thinking: are conventional wisdom and …
This article illustrates how a company’s problems can escalate rapidly from an administrative warning letter to the full weight of the criminal system. The unfortunate subject is ACell, a manufacturer of medical devices derived from porcine urinary bladder material.
FDA recently announced new changes it is making to the Medical Device Reporting (MDR) program as part of its ongoing efforts to increase transparency on device performance, and detection of device-related safety concerns.
Under the Federal Food, Drug, and Cosmetic Act, devices fall into three classes. The premarket approval (PMA) is the route to market for Class III devices, the highest risk medical devices. A Class III device is a device that cannot be classified as a Class I or II device …
Mark Schwartz is quoted in this article