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A REGULATORY PERSPECTIVE OF 505 (b) (2) NEW DRUG APPLICATION.

• Authors : Nagaraju, P.¹; Gowthami, K.²; Lakshmi, T.²

• Source: International Journal of Pharmaceutical, Chemical & Biological Sciences. Jan-Mar2015, Vol. 5 Issue 1, p129-137. 9p.

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Hot-melt extrusion in the pharmaceutical industry: toward filing a new drug application

• Authors : Rui M. A. Pinto; Marta F. Simões; Sérgio Simões

Subjects: 0301 basic medicine; Drug Industry; Computer science

• Source: Drug discovery today. 24(9)

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Timeline: The Common Technical Document: the changing face of the New Drug Application.

• Authors : Molzon, Justina

• Source: Nature Reviews Drug Discovery. Jan2003, Vol. 2 Issue 1, p71. 4p.

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A Qualitative Interview Study on Expanded Access Clinical Trials for Compassionate Use in Japan.

• Authors : Hayashi, Haruto (AUTHOR); Nogita, Takehide (AUTHOR); Maeda, Hideki (AUTHOR)

• Source: Patient Preference & Adherence. Jul2024, Vol. 18, p1471-1479. 9p.

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The Current Status of Drug Discovery and Development as Originated in United States Academia: The Influence of Industrial and Academic Collaboration on Drug Discovery and Development

• Authors : Shunsuke Ono; Ryoka Imai; Tohru Takebe

Subjects: 0301 basic medicine; Drug Industry; Universities

• Source: Clinical and Translational Science

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Salix To Host Conference Call to Provide Update Regarding FDA Review Of XIFAXAN(R) 550 MG Tablets Supplemental New Drug Application.

Subjects: TELECONFERENCING; SALIX Pharmaceuticals Ltd.; DRUG approval

• Source: Biomedical Market Newsletter. 3/21/2011, p511-512. 2p.

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Aggregation and analysis of secondary pharmacology data from investigational new drug submissions at the US Food and Drug Administration

• Authors : Rebecca Racz; Daniel P. Russo; Muriel Saulnier

Subjects: Pharmacology; Drug Industry; business.industry

• Source: Journal of pharmacological and toxicological methods. 111

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Availability of Investigational Medicines Through the US Food and Drug Administration’s Expanded Access and Compassionate Use Programs

• Authors : Jeanie Kim; Joseph S. Ross; Jeremy Puthumana

Subjects: Compassionate Use Trials; medicine.medical_specialty; Databases, Factual

• Source: JAMA Network Open

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Strategic Regulatory Evaluation and Endorsement of the Hollow Fiber Tuberculosis System as a Novel Drug Development Tool: Figure 1

• Authors : Debra Hanna; Klaus Romero; Robert Clay

Subjects: Microbiology (medical); Process management; Evidence-based practice

• Source: Clinical Infectious Diseases. 61:S5-S9

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An Overview of Drug Development in the United States and Current Challenges

• Authors : Sharon Wyatt Moore

Subjects: Clinical Trials as Topic; medicine.medical_specialty; Orphan Drug Production

• Source: Southern Medical Journal. 96:1244-1255

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