Results 111 to 120 of about 5,527 (127)

Postmarketing adverse events associated with onasemnogene abeparvovec: a real-world pharmacovigilance study. [PDF]

Orphanet J Rare Dis
Chen T, Chen Q, Ye J, Wu Y, Liu T, Zhang Y.   +5 more
europepmc   +1 more source

Dalfampridine extended release tablets: 1 year of postmarketing safety experience in the US [PDF]

Barker, , Herbert Henney, Michele Jara
core   +2 more sources

Efficacy and Safety of One Shot of Hyaluronic Acid in Hip Osteoarthritis: Postmarketing Clinical Follow-Up for Real-World Evidence. [PDF]

Open Access Rheumatol
Santamaría Torroba A, Acin Lazaro MP, Gómez-Rubio E, Coronel Granado P.   +3 more
europepmc   +1 more source

Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals.

JAMA Netw Open
Mooghali M, Mohammad A, Wallach JD, Mitchell AP, Ross JS, Ramachandran R.   +5 more
europepmc   +1 more source

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

An Evaluation of VYC-17.5L for the Treatment of Marionette Lines: A Prospective, Open-Label, Postmarketing Study. [PDF]

J Cosmet Dermatol
Cueto SRD, Urdiales Galvez F, Gritti A, Kefalas N, de la Guardia C, Kerson G.   +5 more
europepmc   +1 more source

US FDA's Dose Optimization Postmarketing Requirements and Commitments of Oncology Approvals and the Impact on Product Labels from 2010 to 2022: An Emerging Landscape from Traditional to Novel Therapies. [PDF]

Ther Innov Regul Sci
Gendy JM, Nomura N, Stuart JN, Blumenthal G.   +3 more
europepmc   +1 more source

Regulatory challenges in innovation and evaluation of extracorporeal membrane oxygenation: Database analysis and future perspectives. [PDF]

Chin Med J (Engl)
Jiao G, Wang Y, Guan Y, He X, Miao J, Wu K, Chen J, Luo Q.   +7 more
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