RAPS Convergence 2024 is set to host a must-attend session on CDRH’s Total Product Life Cycle Advisory Program (TAP), promising attendees an exclusive insight into a pioneering initiative aimed at improving the medical device commercialization landscape. Session Details: A Path to Faster Breakthrough Device Commercialization – CDRH’s …
We blogged in February 2022 about the Drug Enforcement Administration’s (“DEA’s”) revocation of Gulf Med Pharmacy’s registration after finding that it failed to exercise its corresponding responsibility by repeatedly filling controlled substance prescriptions that exhibited “obvious red flags of diversion without documenting the resolution of …
FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR. A pre-submission provides the submitter an opportunity to obtain FDA feedback prior to a planned medical device premarket submission. A 513(g) Request for Information is a …
In a short but sweet Guidance issued last week, FDA proposed a dramatic change to the way it evaluates interchangeable biosimilars. For the last 14 years, an applicant could get approval of a biosimilar as a standard biosimilar or an interchangeable biosimilar, but the interchangeable …
This afternoon Hyman, Phelps & McNamara, P.C. (HPM) Director Dara Katcher Levy will present an informative webinar on the newly released AMCP Format for Formulary Submissions version 5.0. The event, titled “New and Improved – AMCP Format for Formulary Submissions v5.0,” aims to educate pharmaceutical …
For more than 50 years, the Drug Enforcement Administration (DEA) has enforced the central mandate of the Controlled Substances Act (CSA) to maintain a closed chain of distribution for drugs with a potential for abuse and diversion. The CSA and regulations promulgated by DEA are …
FDA’s Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) is charged with assuring that drugs marketed in the U.S. are safe, effective, and meet appropriate quality standards. While no office at FDA truly works in a vacuum, we can …
As we have noted for the last year or so, the FTC has been on a mission to clean up the Orange Book by removing what it deems to be “improper” patents. The FTC has put out policy statements, challenged patent listings, tapped Congress, appeared …
Hyman, Phelps & McNamara (HPM) would like to congratulate the 7 rare disease programs selected for the inaugural class of the FDA’s “Support for clinical Trials Advancing Rare disease Treatment” (START) pilot program. The START pilot program was announced last September as a way to …
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 treatment that Congress anticipated. (FDA once estimated that OTC hearing aids would save patients over $3000.) A recent …
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 substantive experience working with: Price calculation and reporting under the Medicaid Drug Rebate Program and the 340B …
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 industry and alleviate some of the stress associated with these activities, last week the FDA issued a draft guidance …
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 (“CSA”) to schedule III. Hyman, Phelps & McNamara, P.C. Director Larry Houck will participate as a …
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 that Palomar Health, one of California’s largest healthcare districts, agreed to pay $250,000 to resolve allegations that numerous …
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 profound effects on the U.S. health care system. At this point, nobody knows all the impacts the rule will have. But …
