Hyman, Phelps & McNamara, P.C. (“HP&M”) is proud to announce the firm has been selected to the 2024 edition of Best Law Firms.  Firms included in the 2024 Best Law Firms ranking are recognized for professional excellence with persistently impressive ratings from clients and peers. To be considered for this milestone achievement, at least one lawyer in the law firm must be recognized in the 2024 edition of Best Lawyers.  HP&M is proud that we have 14 lawyers recognized for their outstanding support of our clients. In 2024, eight of the 14 are new additions.  Those rec ..read more

On January 23-24, 2024, the American Conference Institute (“ACI”) will host its “Advanced Legal, Regulatory and Compliance Forum on OTC Drugs” conference at the Sofitel New York, NY.  Designed for in-house legal and compliance counsel, industry executives, and private practice attorneys working for the OTC drug industry, the event will welcome distinguished industry thought leaders – including from the National Advertising Division and FDA – to share their expertise and strategic insights.  Program highlights include: Spotlight on FDA’s Newly Proposed ACNU Rule Updates on Monog ..read more

By Douglas B. Farquhar & Richard A. Lewis, Senior Regulatory Device & Biologics Expert — We were preparing this blogpost about FDA’s draft guidance on “Remote Interactive Evaluations” when we learned something.  A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections.  In response, we learned that only about seven – and certainly less than 10 – RIEs for manufacturing complia ..read more

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, and Europe. Hyman Phelps & McNamara received the following honors: Tier 1 FDA: Pharmaceutical Tier 1 FDA: Medical Device Additionally, eight professionals are included in LMG’s coverage:  Robert A. Dormer (Hall of Fame), Jeffrey N. Gibbs (Hall of Fame), John A. Gilbert, Gail H. Javitt, Kurt R. Karst, Alan M. Kirschenbau ..read more

The 14th Asia Pacific Symposium on Cochlear Implant and Related Sciences is poised to captivate the global scientific community from November 8-11, 2023, as it convenes in Seoul, Korea.  This prestigious four-day conference promises to deliver a wealth of cutting-edge insights, featuring presentations by eminent scientists and clinicians, all unified under the thought-provoking theme, “Towards Better Speech Perception and Beyond.” A standout highlight of the symposium is the anticipated presentation by Dr. Philip Won, of Hyman, Phelps & McNamara, P.C.  Dr. Won will share his expe ..read more

By Mark A. Tobolowsky & Richard A. Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.”  It finalized a draft guidance published in 2022.  Although fairly short and light on substance, it has the potential to reshape the industry in ways that are sorely needed. In short, Voluntary Consensus Standards (VCS) are intended to be exactly what the name conveys – standards that are adopted by consen ..read more

By Allyson B. Mullen & Gail H. Javitt & Michael D. Shumsky & Philip Won & Adrienne R. Lenz, Principal Medical Device Regulation Expert & Sophia R. Gaulkin & Jeffrey N. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here).  In this post, we summarize the purported basis for this claim as described in the proposed rule (PR) and assess the strength of potential legal challenges should a fi ..read more

By Michelle L. Butler — Just over two years ago, I wrote about the challenges with implementation of the contraceptive mandate in the Patient Protection and Affordable Care Act (ACA).  You will recall that, despite the ACA, a 2019 HRSA Guideline, and guidance from the federal agencies responsible for enforcing the contraceptive coverage requirement of the ACA (the Departments), women seeking contraceptives that were not specifically identified on an FDA Birth Control Guide were encountering roadblocks to accessing the contraceptive of their choice. Since that blog post, an important step ..read more

By Véronique Li, Senior Medical Device Regulation Expert & Anne K. Walsh — In our June blog post, we reported on FDA’s request for comments about its program to receive information from the public alleging misconduct by other companies.  FDA uses this program to help it identify risks and to determine whether further investigation is needed.  Because this program requires information collection from the public, the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501) and its implementing regulations at 5 CFR 1320, requires federal agencies to minimize paperwork burden and ensur ..read more

By Philip Won & Allyson B. Mullen — As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted to FDA using the electronic Submission Template And Resource (eSTAR).  The same template can also be used for De Novo submissions.  Currently, eSTAR is voluntary for medical device De Novo submissions, but FDA has initiated the process of requiring De Novos to be submitted using eSTAR.  On September 29, 2023, FDA released a draft guidance on Electronic Submission Template for Medical Device De Novo Requests. Recap of eSTAR eSTAR is an interactive PDF form des ..read more