-
Mashup Score: 49Study: Many non-oncologic surrogate markers lack meta-analyses linking them to outcomes | RAPS - 24 day(s) ago
Over half of the non-oncologic surrogate markers listed in the US Food and Drug Administration@s (FDA) Adult Surrogate Endpoint Table do not have a meta-analysis of clinical trials evaluating the relationship between the treatment effect associated with the marker and a clinical outcome, according to a recent study published in JAMA.
Source: www.raps.orgCategories: General Medicine News, PayerTweet
-
Mashup Score: 49Study: Many non-oncologic surrogate markers lack meta-analyses linking them to outcomes | RAPS - 24 day(s) ago
Over half of the non-oncologic surrogate markers listed in the US Food and Drug Administration@s (FDA) Adult Surrogate Endpoint Table do not have a meta-analysis of clinical trials evaluating the relationship between the treatment effect associated with the marker and a clinical outcome, according to a recent study published in JAMA.
Source: www.raps.orgCategories: General Medicine News, PayerTweet-
Study: Many surrogate markers used for pivotal trials of products to treat non-oncologic chronic diseases lack meta-analyses linking them to outcomes, raising uncertainty of their validity @JoshuaDWallach @Yale_CRRIT https://t.co/BmmP4LJj7A
-
-
Mashup Score: 0
WASHINGTON @ Sponsors who want to use wearable devices in clinical trials should pay special attention to issues such as ensuring the clinical trials are blinded, data integrity, and whether the devices are fit-for-purpose, according to Guangxing Ken Wang, a statistician at the US Food and Drug Administration@s (FDA) Center for Devices and Radiological Health. He also emphasized that sponsors should consider verifying and validating the devices, and prespecifying their trial endpoints.
Source: www.raps.orgCategories: General Medicine News, Future of MedicineTweet-
FDA statistician offers tips for evaluating wearables for clinical trials https://t.co/6tmtSod1sI https://t.co/DeeoGTsxpI
-
-
Mashup Score: 3
Leaders at the US Food and Drug Administration (FDA) are putting forward strategies to address the epidemic of chronic disease, with a focus on improving the quality of evidence generation for medical interventions through innovative trial design, use of reliable biomarkers, and leveraging artificial intelligence.
Source: www.raps.orgCategories: General Medicine News, CardiologistsTweet-
Great summary of our @US_FDA Perspective on Chronic Disease by @RAPSorg Regulatory Focus by @MaryEllenNY: https://t.co/uTtif5ABku https://t.co/fcP4V5Lrh6 https://t.co/a2utWyBCJG
-
-
Mashup Score: 2FDA finalizes guidance on considerations for evaluating drug’s benefits and risks | RAPS - 7 month(s) ago
The US Food and Drug Administration (FDA) has finalized guidance that clarifies how the benefits and risks of a drug or biologic factored into the agency@s decisions on whether to approve a new drug application (NDA) or biologics license application (BLA). @
Source: www.raps.orgCategories: General Medicine News, Rare DiseaseTweet-
RT @RAPSorg: FDA finalizes guidance on considerations for evaluating drug’s benefits and risks. https://t.co/DO1DgLtPm1
-
-
Mashup Score: 0CDRH official: Novel device submissions show medtech sector strength post-COVID | RAPS - 9 month(s) ago
Now that the nation has transitioned out of the emergency phase of the COVID-19 pandemic, top officials at the US Food and Drug Administration@s (FDA) device center say they have seen a @resurgence@ in novel device applications, indicating a healthy innovation ecosystem. The agency is also confident that companies will continue to transition their products with emergency use authorization (EUA) to traditional marketing authorizations, and that the center will meet its staffing commitments under the latest user fee deal.
Source: www.raps.orgCategories: Healthcare Professionals, Latest HeadlinesTweet-
#FDA #CDRH official: Novel #medicaldevices submissions show #medtech sector strength post-COVID | #regulatory https://t.co/Xm3obdzpIL
-
-
Mashup Score: 2FDA offers draft guidance for registries as RWD - 2 year(s) ago
The US Food and Drug Administration (FDA) released draft guidance on the use of registries in regulatory decision making, adding another piece to the puzzle of how the agency will consider real-world data (RWD) when considering a new drug indication or assessing post-approval requirements.
Source: www.raps.orgCategories: Latest Headlines, PayerTweet-
@US_FDA @reshmagar Coincidentally, FDA released draft guidance yesterday on use of registry data to support regulatory decision-making. Some important differences versus EHR/claim data. Generally, guidance does a nice job of highlighting strengths & limitations @MaryEllenNY https://t.co/cTccRFFcP2
-
-
Mashup Score: 1
Some said that EUAs were necessary to get the pediatric population vaccinated quickly to achieve herd immunity as the country emerges from the pandemic and that these vaccines should be available soon as the fall and flu season approach and the risk of contracting respiratory infections increases.
Source: www.raps.orgCategories: Hem/Oncs, Latest HeadlinesTweet-
@VPrasadMDMPH @JulienneB_MD Actually members of the advisory panel specifically state their concern is myocarditis. https://t.co/5zqZntI3Z9
-
-
Mashup Score: 1
FDA has acknowledged the “significant attention and controversy” resulting from the Aduhelm decision. On 9 July, Janet Woodcock, acting director of the FDA, asked the Office of Inspector General to conduct an investigation into Aduhelm’s approval.
Source: www.raps.orgCategories: Hem/Oncs, Latest HeadlinesTweet-
Nice piece in @RAPSorg about the series of articles in @JAMAInternalMed about accelerated approval and aducanumab, including ours. https://t.co/9dLkNjFMkn https://t.co/G2iqKMUYJo
-
-
Mashup Score: 0
FDA has acknowledged the “significant attention and controversy” resulting from the Aduhelm decision. On 9 July, Janet Woodcock, acting director of the FDA, asked the Office of Inspector General to conduct an investigation into Aduhelm’s approval.
Source: www.raps.orgCategories: Hem/Oncs, Latest HeadlinesTweet-
@barttels2 @jasonkarlawish @notchuraverage1 @mikejohansenmd @rvaughnmd @ProfRobHoward @US_FDA @RebeccaDRobbins @PamBelluck @DrWoodcockFDA @OIGatHHS @biogen @adamfeuerstein @NicholasFlorko @matthewherper @damiangarde @r_merrick @bmj_latest @peterbachmd @joewalkerWSJ @XavierBecerra @HHSGov @skepticalraptor @VPrasadMDMPH @USGAO @FDAWhistleblow1 @Yale @gregggonsalves @cmrherder @jmhooker @HouseDemocrats @RepMaloney @FrankPallone @rachelcohrs @MedicareGov @ShannonBrownlee @JeanneLenzer1 @CMSGov @ZacharyBrennan @JAMAInternalMed @oncology_bg @akesselheim @jsross119 @BenMazer @TheAtlantic @congressdotgov @OversightDems @higginsdunn @US_FDA defends Aduhelm's accelerated approval, while others call for reform https://t.co/8lRYB5ruIp via @jeffbcraven
-
Study: Many surrogate markers used for pivotal trials of products to treat non-oncologic chronic diseases lack meta-analyses linking them to outcomes, raising uncertainty of their validity @JoshuaDWallach @Yale_CRRIT https://t.co/BmmP4LJj7A