For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. This was …
End-of-Phase 2 (EOP2) is, in our view, one of the most critical moments in drug development. It’s the moment at which a drug sponsor selects, and seeks FDA agreement on, its critical Phase 3 study parameters: dose, eligibility criteria and endpoints, to name a few. …
On June 17, 2021, FDA gave notice of an upcoming public workshop focused on clinical trial designs for progressive multifocal leukoencephalopathy (PML). PML is a rare disease that occurs when the JC virus (JCV), generally thought to lie dormant in the adult population, takes advantage …
In October 2020, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) published a Final Rule (which we summarized here) that implemented Section 804 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 384, to allow states and …
While typically, FDA is responsible for setting forth its own agenda and enforcing compliance with its own regulations, the Trump Administration’s HHS, on its way out the door in late 2020, took the unusual steps of withdrawing an important FDA Compliance Policy Guide, “Marketed Unapproved …
Yesterday’s FDA approval of Biogen’s Alzheimer’s drug, Aduhelm (aducanumab-avwa), is historic and is of a magnitude that it may be harbinger for future Agency actions, especially in neuropsychiatric conditions. This has been a decision we’ve been closely following. So much so, in November, right after …
The RAPS Wisconsin Chapter is hosting a webcast on Wednesday, June 23, 2021, discussing device requirements for drug-led combination products. Hyman, Phelps & McNamara, P.C.’s Adrienne Lenz will be the speaker. This webcast will cover U.S. FDA requirements applicable to sponsors of drug-led drug/device combination …
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. This year was no different. Recently, FDLI published on …
While federal efforts to address prescription drug prices are debated, states have continued to pursue their own measures that require drug manufacturers and other entities in the drug supply chain to disclose information about pricing. (See our previous coverage of such state laws here, here …
This sentiment is being exchanged by many with family, friends and colleagues looking forward to what we all hope is a near future in which we meet in person for work, play and everything else life has to offer. We at Hyman, Phelps & McNamara, …
The past two weeks have seen two noteworthy developments relating to CMS’s Medicaid Drug Rebate Program (MDRP) regulations. 1. PhRMA Sues CMS Challenging MDRP Rule Curbing Patient Assistance In December 2020, CMS published a final rule making several changes to the MDRP regulations. See our post …
NDA approval – that pinnacle of drug development – marks a moment of success for both FDA and the drug applicant. The regulated and the regulator, having worked together for years, place a novel or improved therapy, with adequate directions for its use, in the …
Hyman, Phelps & McNamara, P.C., is proud to announce that Frank J. Sasinowski, a Director at the firm, this past Saturday was awarded by Pope Francis the “2021 Pontifical Hero Award for Inspiration” for his “unwavering advocacy for those who live with rare diseases.” The award …
On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The notice was given to Acceleron Pharma, Inc., for failure to submit the required information following completion of a clinical trial evaluating the safety …
Over the past few days there’s been an avalanche of FDA-related legislation introduced in both the U.S. House of Representatives and the U.S. Senate. Some of the bills introduced are related to a House Judiciary Antitrust Subcommittee hearing, titled “Addressing Anticompetitive Conduct and Consolidation in …
