Results 131 to 140 of about 25,533 (219)

Adverse effects of biologics used to treat asthma. [PDF]

Ther Adv Respir Dis
Sitek A, Chiarella SE, Pongdee T.
europepmc   +1 more source

Direct oral anticoagulant approvals by four major regulatory agencies: a cross-sectional analysis of premarket and postmarket evidence. [PDF]

BMJ Open
Mooghali M, Zhou T, Ross JS.
europepmc   +1 more source

Consultation report - considerations for a regulatory pathway for bivalent Salmonella Typhi/Paratyphi A vaccines for use in endemic countries.

Vaccine
Ibarz-Pavon AB, Bielsky MC, Bose R, Cavaleri M, Crump JA, Hombach J, Kaslow DC, Khaman F, MacLennan CA, Mehring-LeDoare K, Pollard AJ, Quadri F, John J, Wilder-Smith A.   +13 more
europepmc   +1 more source

Safety Evaluation of the Novel Cocktail of Monoclonal Antibodies for Postexposure Prophylaxis in Category III Animal Exposures. [PDF]

J Glob Infect Dis
Shankaraiah RH, Masthi NRR, Poornima MK, Kiruffi V, Sowmyashree S, Dutta T, Mahajan M, Desai S.   +7 more
europepmc   +1 more source

Sustainable Access to Data for Postmarketing Medical Product Safety Surveillance under the Amended HIPAA Privacy Rule [PDF]

, 2015
Evans, Barbara J.
core   +2 more sources

Real-World Utilization Patterns, Safety, and Efficacy of Tafamidis in Patients With Hereditary Transthyretin Amyloidosis in Japan. [PDF]

Curr Ther Res Clin Exp
Konishi H, Abe H, Matsumoto N, Endo Y, Sekijima Y, Ueda M, Ando Y.   +6 more
europepmc   +1 more source

Description and Validation of a Novel AI Tool, LabelComp, for the Identification of Adverse Event Changes in FDA Labeling. [PDF]

Drug Saf
Neyarapally GA, Wu L, Xu J, Zhou EH, Dang O, Lee J, Mehta D, Vaughn RD, Pinnow E, Fang H.   +9 more
europepmc   +1 more source

Pregnancy Outcomes in Patients Treated with Upadacitinib: Analysis of Data from Clinical Trials and Postmarketing Reports. [PDF]

Drug Saf
Mahadevan U, Levy G, Gensler L, Ali M, Lacerda AP, Wegrzyn L, Palac H, Bhutani-Jacques T, Long M, Clowse MEB, Kimball AB, Chambers C, Scialli AR.   +12 more
europepmc   +1 more source

US regulatory compliance for medical combination products: an overview. [PDF]

Front Med Technol
Singh MV, Apshingekar P, Gandhi S, Singh OV.   +3 more
europepmc   +1 more source

Drug Safety: It\u27s a Learning Process [PDF]

, 2012
Eng, Vanessa
core   +1 more source