Results 171 to 180 of about 25,533 (219)

Analysis of Adverse Events Associated With Dental Local Anaesthetics Using Food and Drug Administration Adverse Event Reporting System Data. [PDF]

Int Dent J
Bayram F, Akici A, Apari AM, Aydin V.
europepmc   +1 more source

Premarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies.

JAMA Netw Open
Mooghali M, Wallach JD, Ross JS, Ramachandran R.   +3 more
europepmc   +1 more source

Trust but Verify: Lessons Learned for the Application of AI to Case-Based Clinical Decision-Making From Postmarketing Drug Safety Assessment at the US Food and Drug Administration.

J Med Internet Res
Ball R, Talal AH, Dang O, Muñoz M, Markatou M.   +4 more
europepmc   +1 more source

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Evaluation of the Relative Abuse of an OROS Extended-release Hydromorphone HCI Product

The Clinical Journal of Pain, 2018
Objective: Formulating prescription opioids to limit abuse remains a priority. OROS extended-release (ER) hydromorphone HCl (EXALGO) may have lower abuse potential than many other opioid products. Three postmarketing studies of the relative abuse liability of OROS hydromorphone ER were conducted.
Butler, Stephen F., McNaughton, Emily C., Black, Ryan A., Cassidy, Theresa A   +3 more
openaire   +4 more sources

Photosensitivity associated with anaplastic lymphoma kinase inhibitors: A review of postmarketing cases reported to FDA and published in the literature

Photodermatology, Photoimmunology & Photomedicine, 2022
To the Editor, The U.S. Food and Drug Administration (FDA) has approved five anaplastic lymphoma kinase (ALK) inhibitors (i.e., crizotinib, ceritinib, alectinib, brigatinib, lorlatinib) since 2011 to treat ALKpositive, metastatic nonsmall cell lung ...
Connie Cheng, Afrouz Nayernama, S. Jones, Melissa Reyes   +3 more
semanticscholar   +1 more source

The First 4 Years of Postmarketing Safety Surveillance Related to the MitraClip Device: A United States Food and Drug Administration MAUDE Experience.

The Journal of invasive cardiology, 2020
OBJECTIVE The MitraClip (Abbott) is a commercially available device to perform percutaneous transcatheter mitral valve repair (TMVR) for patients with symptomatic mitral regurgitation (MR).
Chetaj A. Mahabir, E. DeFilippis, S. Aggarwal, A. Bath, Arman Qamar, Nilay K Patel, Andrew M. Goldsweig, M. Vaduganathan   +7 more
semanticscholar   +1 more source

Active Surveillance of Postmarket Medical Product Safety in the Federal Partners' Collaboration

Medical Care, 2012
After half a century of monitoring voluntary reports of medical product adverse events, the Food and Drug Administration (FDA) has launched a long-term project to build an adverse events monitoring system, the Sentinel System, which can access and evaluate electronic health care data to help monitor the safety of regulated medical products once they ...
Trinka S. Coster, Francesca E. Cunningham, Judith A. Racoosin, Chris Worrall, Melissa A. Robb, Summer Chapman   +5 more
openaire   +3 more sources

Role of postmarketing surveillance in contemporary medicine.

Annual Review of Medicine, 2011
Contemporary medicine is a large and complex system involving many participants, all of whom play a critical role in managing the risks intrinsic to medical product use. Despite the robust premarket review and approval process of the U.S.
J. Woodcock, R. Behrman, G. D. Dal Pan
semanticscholar   +1 more source

Safety of recent ophthalmic drugs and devices for wet macular degeneration

Current Opinion in Ophthalmology, 2023
Purpose of review With frequent antivascular endothelial growth factors (VEGF) injections well established as the standard of care in neovascular age-related macular degeneration (nAMD), focus has now shifted towards decreasing treatment burden without ...
Elise Timtim, Christina Y. Weng, Avni P. Finn   +2 more
semanticscholar   +1 more source

Postmarketing surveillance of new food ingredients: design and implementation of the program for the fat replacer olestra.

Regulatory toxicology and pharmacology : RTP, 2001
Following U.S. Food and Drug Administration (FDA) approval for the use of olestra, a noncaloric fat substitute (brand name Olean) in food snacks, the manufacturer agreed to provide safety updates on market experience to the FDA.
Candice L. Slough, R. Miday, Nora L. Zorich, Judith K. Jones   +3 more
semanticscholar   +1 more source