Antiretroviral Use for HIV Prevention During Pregnancy: The Need to Strengthen Regulatory and Surveillance Systems in Africa. [PDF]
Schaefer R+11 more
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One-year Safety and Effectiveness of Ustekinumab in Patients With Crohn's Disease: The K-STAR Study. [PDF]
Lee CK+17 more
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Fibrosing colonopathy associated with cysteamine bitartrate delayed-release capsules in cystinosis patients. [PDF]
Kishk OA+4 more
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Postmarketing Safety Concerns of Teprotumumab: A Real-World Pharmacovigilance Assessment.
Huang J, Su A, Yang J, Zhuang W, Li Z.
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Emerging Isseus in FDA Regulation: Warning Letters, Internet Promotion, and Tobacco [PDF]
Senger, Jeffrey M.
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Has risk management plan system influenced the speed of package insert revisions in Japan? [PDF]
Kameyama N, Hosaka A, Maeda H.
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Harmonization of individual case safety reports transmission requirements among PAHO reference authorities: a review of their current regulation. [PDF]
Lomeli-Silva A+4 more
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Overview of global monitoring systems for the side effects and adverse events associated with medicinal cannabis use: a scoping review using a systematic approach. [PDF]
Wang RQ, Bonomo YA, Hallinan CM.
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Navigating Oncology Clinical Trials: From Drug Development to Delivery. [PDF]
Bourgeois J, Goodman MS, Braga C.
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The FDA and the Tort System: Postmarketing Surveillance, Compensation, and the Role of Litigation [PDF]
Struve, Catherine T
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