FDA sends warning letter to community hospital review board over … – Endpoints News

An in­sti­tu­tion­al re­view board (IRB) for a hos­pi­tal in South Flori­da has been hit with a warn­ing let­ter from the FDA over con­cerns raised dur­ing an in­spec­tion late in 2021.
The let­ter, sent ear­li­er this month to Sima Marzban, the VP of re­search and aca­d­e­m­ic af­fairs for the Larkin Com­mu­ni­ty Hos­pi­tal In­sti­tu­tion­al Re­view Board, states that an in­spec­tion was con­duct­ed in No­vem­ber to see if the hos­pi­tal’s hu­man stud­ies com­plied with FDA re­quire­ments. The site was is­sued a Form ‘483, how­ev­er, in­ves­ti­ga­tors no­ticed af­ter re­view­ing the IRB’s re­sponse that it “did not ad­here to ap­plic­a­ble statu­to­ry re­quire­ments” that gov­ern the pro­tec­tion of hu­man sub­jects.
Specif­i­cal­ly, in­ves­ti­ga­tors took is­sue with how the IRB re­viewed pro­posed re­search. The agency ac­cused the IRB of re­view­ing and ap­prov­ing re­search at meet­ings in which a ma­jor­i­ty of mem­bers (in­clud­ing one “non­sci­en­tist”) were not present, go­ing against re­quire­ments. In the re­sponse to the FDA, the IRB promised it would take steps to cor­rect this, but the agency wasn’t com­plete­ly sat­is­fied.
“We are un­able to per­form an in­formed eval­u­a­tion of the IRB’s writ­ten re­sponse be­cause you did not pro­vide a cor­rec­tive ac­tion plan that, if prop­er­ly car­ried out, would pre­vent the re­cur­rence of this type of vi­o­la­tion in the fu­ture. Specif­i­cal­ly, you did not pro­vide suf­fi­cient de­tails on the pro­ce­dures you are ini­ti­at­ing and how you will en­sure that a ma­jor­i­ty of the IRB mem­bers, in­clud­ing at least one mem­ber whose pri­ma­ry con­cerns are in non­sci­en­tif­ic ar­eas, will be present at con­vened meet­ings when pro­posed FDA-reg­u­lat­ed re­search is un­der re­view,” the let­ter said.
The let­ter al­so said that the IRB did not main­tain doc­u­men­ta­tion of its ac­tiv­i­ties, in­clud­ing a list of cur­rent mem­bers, and that it had failed to en­sure its process for pro­vid­ing pa­tients with in­for­ma­tion as a part of in­formed con­sent was up to code.
More specif­i­cal­ly, in­ves­ti­ga­tors ac­cused the IRB of  fail­ing to make sure that the in­formed con­sent doc­u­ments for two clin­i­cal tri­als con­tained a state­ment no­ti­fy­ing the pa­tient that their tri­al in­for­ma­tion “has been or will be sub­mit­ted for in­clud­ing in the clin­i­cal tri­al reg­istry data­bank.”
The re­sponse to the FDA did note that “ac­tions were in mo­tion to es­tab­lish best prac­tices” and that fu­ture tri­al doc­u­ments would in­clude the state­ment. How­ev­er, the let­ter notes that the re­sponse did not in­clude an ac­tion plan for pre­vent­ing the re­cur­rence of this vi­o­la­tion in the fu­ture.
“Specif­i­cal­ly, you did not pro­vide suf­fi­cient de­tails on the best prac­tices you are es­tab­lish­ing and how you will en­sure that the ICDs will con­tain the state­ment,” the let­ter said.
End­points News reached out to Larkin Com­mu­ni­ty Hos­pi­tal, but did not re­ceive a re­sponse by press time.
George Scangos, one of the all-time great biotech CEOs, says the time has come to turn over the reins one last time.
The 74-year-old biotech legend spent close to three decades in a CEO post. The first was at Exelixis — which is still heavily focused on a drug Scangos advanced in the clinic. The second “retirement” was at Biogen, where he and his team were credited with a big turnaround with the now fading MS blockbuster Tecfidera. And the third comes at Vir, where he traded in his Big Biotech credentials for a marquee founder’s role back on the West Coast, hammering out a Covid-19 alliance with Hal Barron — then R&D chief at GSK — and breaking new ground on infectious diseases with some high-powered venture players.
Unlock this article along with other benefits by subscribing to one of our paid plans.
Last July, Jeanne Loring stood on a dirt road surrounded by Florida swampland and watched as a nearby SpaceX rocket blasted into the sky. The payload included a very personal belonging: cell clusters mimicking parts of her brain.
For more than two decades, Loring has been at the forefront of a stem cell field that always seems on the brink of becoming the next thing in medicine, but has been slow to lift off.
Unlock this article along with other benefits by subscribing to one of our paid plans.
Merck is slamming the brakes on a late-stage Keytruda study in prostate cancer after an interim analysis showed no improvement in survival, the company announced on Wednesday. However, the pharma giant cushioned the blow with a positive look at a separate study in biliary tract cancer.
An independent data monitoring committee reviewing the Phase III KEYNOTE-991 trial saw no improvement in overall survival or radiographic progression-free survival in a Keytruda combination group compared to the control group, Merck said in a news release. The trial was conducted in more than 1,200 patients with metastatic hormone-sensitive prostate cancer (mHSPC), or those whose cancer is controlled by keeping testosterone levels as low as would be expected after castration.
Pharma marketers are known for recruiting both doctors and celebrities for ad campaigns. But Novartis has both in one person for its dry eye disease medicine Xiidra.
Actor Ken Jeong is no longer a practicing physician, but he is still a celebrity Novartis spokesperson for the past 18 months, and he’s now turning up the celebrity for the brand.
Novartis’ latest TV commercial for Xiidra is a movie trailer spoof with Jeong squinting and rubbing his eyes as he walks through a park, while a loud, ominous voiceover intones: “In a world where dry eye symptoms keep coming back … one man learns the truth.”
Unlock this story instantly and join 157,200+ biopharma pros reading Endpoints daily — and it’s free.
What happens when you combine a country music star with a trending health issue and throw in a good measure of TikTok and Instagram?
For Sanofi’s “Knowing RSV” campaign, it’s meant broader awareness for a common virus that many parents don’t know much about. One common misconception, for example, is that respiratory syncytia virus (RSV) only affects infants who are born prematurely or have other health issues. However, 72% of infants hospitalized with RSV are healthy, full-term babies, said Ayanna Santos, head of Sanofi’s RSV franchise in the US.
Once again the FDA’s panel of outside oncology experts will have to weigh in on whether or not to grant another indication for Roche’s potential blockbuster cancer drug Polivy, which some analysts have said could reap $2.4 billion in peak annual sales.
Approved in June 2019 under the accelerated pathway, the antibody drug conjugate Polivy was OK’d in combo with bendamustine and rituximab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies.
Unlock this story instantly and join 157,200+ biopharma pros reading Endpoints daily — and it’s free.
The European Medicines Agency said yesterday that it’s changing how it signs off on orphan designations for drugs targeting inherited retinal dystrophies (IRD) in order to make sure that patients are not left out because of the limitations of the previous orphan designation terms.
Inherited retinal dystrophies are a group of genetic and progressive blinding diseases.
The Committee for Orphan Medicinal Products for the EMA announced the changed policy, which the organization said was supported by input from experts and patients of IRD, as well as a review of scientific literature and 64 active orphan designations in the specific eye diseases in the EU.
Gene editing and artificial intelligence were the top trending topics on social media among industry experts at the JP Morgan Healthcare Conference this year, according to The Harris Poll.
Among leading CEOs, JPM Chase’s own Jamie Dimon, along with Flagship’s Noubar Afeyan, Sage Therapeutics’ Barry Greene, Biogen’s Chris Viehbacher and Moderna’s Stéphane Bancel were the most discussed chief executives among Harris’ JPM expert network.
Unlock this story instantly and join 157,200+ biopharma pros reading Endpoints daily — and it’s free.
Swiss contract manufacturer Lonza recorded growth in its latest results posted for 2022, but it expects some slowdown for Covid sales.
According to the manufacturer on Wednesday, it reported sales of CHF 6.2 billion ($6.7 billion), a growth in sales of 15%. The financial boost was a result of a combination of its general business performance and a “Covid-related sales peak” last year, which gave a lift to its sales and margin.
Bioscience & Technology Business Center
The University of Kansas
Lawrence, Kansas
© Endpoints Company 2023
If you’re already an Endpoints subscriber, enter your email below for a magic link that lets you log in quickly without using a password. Please note the magic link is one-time use only and expires after 24 hours.
We’ll e-mail you a link to set a new password. Please note this link is one-time use only and is valid for only 24 hours.


Leave a Comment