The End* of a Long and Winding Road: FDA Publishes Final LDT Rule (*Or Is It?)
By Jeffrey N. Gibbs & Allyson B. Mullen —On April 29, 2024, FDA announced its finalization of the laboratory developed test (LDT) rule. The final rule will be published in the Federal Register on...
View ArticleDEA Concurs: Marijuana Meets Schedule III Criteria
By Larry K. Houck —The Associated Press reported on Tuesday following confirmation by five anonymous individuals with knowledge that the Drug Enforcement Administration (“DEA”) is moving to reschedule...
View ArticleCan a Device Be Found Not Substantially Equivalent Because of Cybersecurity...
By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert —FDA recently issued a draft guidance which would update the agency’s...
View ArticleWhen Worlds Collide: The Theory of Real-World Evidence Meets Reality
By Jeffrey N. Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert —FDA has long touted the use of real-world evidence (RWE). Extolling RWE, FDA has said “RWE can be...
View ArticleJoin Us for an HPM/Lighthouse Labs Webinar: What the FDA’s Final Rule Means...
On April 29, the FDA issued their long-awaited, controversial Final Rule governing the oversight of laboratory developed tests (LDTs). This new rule will dramatically alter the LDT regulatory...
View ArticleHospitals: Do You Know Where Your Controlled Substances Are?
By Larry K. Houck —Employee diversion of controlled substances from hospitals has been an issue since at least 1986 when I became a diversion investigator with the Drug Enforcement Administration...
View ArticleUpcoming EveryLife Foundation Scientific Workshop on May 21, 2024 will...
By Sarah Wicks —On May 21, 2024, the EveryLife Foundation for Rare Diseases (ELF) will host a Scientific Workshop at the National Press Club in Washington, D.C. aimed at identifying and characterizing...
View ArticleBuckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana
By Larry K. Houck —Last August Health and Human Services (“HHS”) recommended rescheduling marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. We wondered how...
View ArticleWhen Worlds Collide: The Theory of Real-World Evidence Meets Reality – Part II
By Jeffrey N. Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert —We recently blogged about the Center for Devices and Radiological Health’s (CDRH) reluctance to make...
View ArticleHouse and Senate Members Introduce Long-Shot Resolutions to Repeal FDA’s LDT...
By Steven J. Gonzalez —On May 15th and 16th, respectively, Senator Rand Paul and Congressmen Brad Finstad and Dan Crenshaw introduced Senate and House resolutions “providing for congressional...
View ArticleJennifer Newberger Returns to HPM as a Director After Stints with Apple,...
Hyman, Phelps & McNamara, P.C. (HPM) proudly announces the return of Jennifer Newberger as a Director, further boosting its already robust medical device practice. Jennifer’s combination of...
View ArticleD.C. Circuit Sides with Manufacturers in Latest 340B Contract Pharmacy Case
By Sophia R. Gaulkin & Alan M. Kirschenbaum —Last week, the United States Court of Appeals for the District of Columbia ruled that Section 340B of the Public Health Service Act does not prohibit...
View ArticleWomen’s Health a Focus for FDA and Biden Administration
By Adrienne R. Lenz, Principal Medical Device Regulation Expert —FDA’s Office of Women’s Health (OWH) recently celebrated its 30th anniversary. This office was formed in 1994 to promote the inclusion...
View ArticleThe OIG Don’t Like That: Rockin’ The Casbah, Rockin’ the Casbah
By Jeffrey N. Wasserstein —Today’s email brings an interesting, and somewhat confusing settlement of what should have been an ordinary antikickback statute case, and may bring about a clash between...
View ArticleWill the LDT Rule Make it Easier for Sports Dopers to Go Undetected?
By Jeffrey N. Gibbs & Allyson B. Mullen —The FDA’s new rule for laboratory developed tests (LDTs), unless overturned through litigation (see here), by legislation, or the election, is going to have...
View ArticleMore Diversion Cases and WCF’s Opioid & Fentanyl Abuse Management Summit
By Larry K. Houck —It seems as though we cannot get through a week without hearing about controlled substance diversion by employees at another hospital or healthcare facility. We learned this week...
View ArticleHP&M’s Larry Houck A Panelist in FDLI’s Marijuana Rescheduling Webinar
Last month the Department of Justice and the Drug Enforcement Administration submitted a notice of proposed rulemaking to reschedule cannabis from schedule I under the federal Controlled Substances Act...
View ArticleKnock, Knock – FDA Issues Guidance on Best Processes and Practices During...
By Sarah Wicks & Anne K. Walsh —Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” In an effort to clarify for...
View ArticleHP&M Seeks Attorney with Significant Experience in Government Discount...
Hyman, Phelps & McNamara, P.C. (HP&M) seeks to add an experienced attorney (7+ years) to our government discount program and price reporting practice. Our ideal candidate will have significant...
View ArticleOTC Hearing Aids: “Nothing to See Here” Says GAO Report
By Sara W. Koblitz & Jeffrey N. Gibbs —It’s been over a year and a half since Over-the-Counter (“OTC”) hearing aids became legal, and it’s not clear that they’ve made the difference in hearing loss...
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