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Subject : government regulation Publisher : springer nature Format : Academic Journals Format : Academic Journals Filter by : Subject

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Academic Journal

A Novel Case Study of the Use of Real-World Evidence to Support the Registration of an Osteoporosis Product in China.

Authors : Storm, Neal E.; Chang, Wen; Lin, Tzu-Chieh

Subjects: THERAPEUTIC use of monoclonal antibodies; DRUG approval; DATA qualityCHINA

Source: Therapeutic Innovation & Regulatory Science; Jan2022, Vol. 56 Issue 1, p137-144, 8p

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Academic Journal

Regulatory Requirements and Innovation: A Comparison of the Dermatologic Antifungal Drug Product Markets in Brazil and United States.

Authors : Kollross, Bianca; Cunha-Filho, Marcilio; Gelfuso, Guilherme Martins

Subjects: ANTIFUNGAL agents; DERMATOLOGIC agents; DEVELOPING countriesBRAZIL; UNITED StatesUNITED States. Food & Drug Administration

Source: Therapeutic Innovation & Regulatory Science; Sep2019, Vol. 53 Issue 5, p661-668, 8p

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Academic Journal

Effect of regulation reform on clinical trials for registering novel therapeutic agents in Taiwan: a chronological analysis.

Authors : Sun, I-Chen; Shy, Horng-Shing; Liao, Tzu-Ya

Subjects: CLINICAL trial laws; RECORDING & registration; RULESTAIWAN

Source: Investigational New Drugs; Jun2016, Vol. 34 Issue 3, p364-370, 7p

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