Who You Gonna Email? Digital Health Question Busters!
By Jennifer D. Newberger —Though digital health is not new, it can still often be difficult to determine with precision the regulatory requirements applicable to a particular software product....
View ArticleWhile the Orphan Battles Wage, Jazz Takes a Loss
By Sara W. Koblitz —The fight between Jazz, Avadel, and FDA over narcolepsy drug sodium oxybate has been a long and arduous one. Starting in 2022 with a patent certification requirement, both Jazz and...
View ArticleTo 513(g) or not to 513(g)? That is the question
By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Gibbs —In most instances, it is clear if a product will be considered a “device” under the Federal Food, Drug, and Cosmetic Act...
View ArticleRegulator and Funder? FDA’s Orphan Products Grants Program awards significant...
By Sarah Wicks & James E. Valentine —The U.S. Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants...
View ArticleFDA’s Proposal to Remove Oral Phenylephrine from the OTC Monograph Isn’t a...
By Deborah L. Livornese & JP Ellison —On November 8, 2024, FDA issued a proposed order to remove the oral decongestant ingredient phenylephrine (including both phenylephrine hydrochloride and...
View ArticleThe Prophecy: How will the FDA under the New Trump Administration Handle OPDP...
By Jeffrey N. Wasserstein & Dara Katcher Levy —We recently saw an interesting Instagram post aimed at Swifties disappointed in the election results. It noted that Tay Tay released four albums...
View ArticleMAHA, Nutrition, and the FDA
By Ricardo Carvajal —Among the more interesting developments in the recent election was the emergence of Robert Kennedy as a prominent figure in the MAGA movement – and the collateral emergence of the...
View ArticleFDA and the Device Industry: Friends or Foes?
By Jennifer D. Newberger —“An open foe may prove a curse, but a pretended friend is worse.” When the poet John Gay wrote these words in 1727, the idea of an administrative agency like the FDA was...
View ArticleEven in “Unprecedented” Times, There is Precedent
By JP Ellison —The word unprecedented has been used a lot in the past two weeks. Perhaps appropriately. Below is some precedent that’s been on this blogger’s mind recently and that may be relevant...
View ArticleEvidence v. Belief: What a Kennedy Appointment Could Mean to FDA and Public...
By Jennifer D. Newberger & Jeffrey N. Gibbs —On Thursday, November 14, President-Elect Trump announced his pick of Robert Kennedy, Jr., for Secretary of Health and Human Services (HHS). Although...
View ArticleGAO Report Recommends Retaining FDA’s Drug Inspectional Workforce As Agency...
By John W.M. Claud & Mark I. Schwartz —Over the past few days, we’ve been blogging about changes that are sure to come to FDA under Trump 2.0. Calls to more generally gut Federal agencies are...
View ArticleNew Draft Guidance Provides Detailed (and Burdensome) Recommendations for...
By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Kristy Katzenmeyer-Pleuss, Regulatory and Biological Safety Consultant* —FDA recently issued a draft guidance, Chemical Analysis...
View ArticleIt’s a Three-Peat: DEA and HHS Extend Telemedicine Flexibilities Until...
By Karla L. Palmer —In a Temporary Rule announced on November 19, 2024, DEA with input from HHS again extended current telemedicine flexibilities, which were first initiated on January 31, 2020 at the...
View ArticleGentlemen, Start Your Engines: DEA’s Marijuana Rescheduling Hearing Begins...
By Larry K. Houck —Last May the Department of Justice (“DOJ”) and the Drug Enforcement Administration (“DEA”) issued a Notice of Proposed Rulemaking (“NPRM”) to transfer marijuana from schedule I of...
View ArticleQuiet on the Set? Forbidding FDA To Take Photographs During An Inspection Can...
By Douglas B. Farquhar —A recent Warning Letter reflects an FDA citation of a company for refusing to permit FDA Investigators to take photographs during an inspection. We haven’t seen an FDA Warning...
View ArticleHow Many Hours are Really in a Day?
By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Kristy Katzenmeyer-Pleuss, Regulatory and Biological Safety Consultant* —We recently blogged on FDA’s draft guidance, Chemical...
View Article“If You’ve Got Legitimate Suspenders, Don’t Have an Unconstitutional Belt:”...
By Kurt R. Karst —On August 30, 2024, we posted on what was then the most recent version of S. 142, the Preserve Access to Affordable Generics and Biosimilars Act. Some version of the bill, which...
View ArticleFDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What...
By Mark A. Tobolowsky & Charles G. Raver & James E. Valentine —On November 19, 2024, FDA released a draft guidance titled “Frequently Asked Questions – Developing Potential Cellular and Gene...
View ArticleHPM and Riparian to Co-Host Webinar on CMS Misclassification Penalties Rule
On Wednesday, December 11, Hyman, Phelps & McNamara, P.C. (HPM) and Riparian LLC will co-host a webinar on an important CMS rule imposing penalties for misclassification of drugs and other...
View ArticleReminder: HPM and Riparian to Co-Host Webinar on CMS Misclassification...
On Wednesday, December 11, Hyman, Phelps & McNamara, P.C. (HPM) and Riparian LLC will co-host a webinar on an important CMS rule imposing penalties for misclassification of drugs and other...
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