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FDA MODERNIZES CONTROLLED CORRESPONDENCE INTERACTIONS WITH INDUSTRY.

• Authors : Middleton, Saundra; Graborov, Daniil; Hill, Shannon

Subjects: UNITED States. Food & Drug Administration; PHARMACEUTICAL industry; GENERIC drugs

• Source: Applied Clinical Trials. Apr2019, Vol. 28 Issue 4, p7-7. 1p.

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PDUFA V Changes To Speed Drug Development and Approvals.

• Authors : Wechsler, Iill

• Source: Applied Clinical Trials. Jun2013, Vol. 22 Issue 6, p10-10. 1p.

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FDA Gains Support for e-Submissions, Standards.

• Authors : Wechsler, Jill

Subjects: UNITED States. Food & Drug Administration; ELECTRONIC records; O'NEILL, RobertUNITED States

• Source: Applied Clinical Trials. Jun2011, Vol. 20 Issue 6, p18-19. 2p.

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Search for Stability at FDA.

• Authors : Wechsler, Jill

Subjects: UNITED States. Food & Drug Administration; GOVERNMENT agency reorganization; CENTER for Drug Evaluation & Research (U.S.)UNITED States

• Source: Applied Clinical Trials. Dec2005, Vol. 14 Issue 12, p12-14. 2p.

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Generic Drugs Making Waves.

• Authors : Henderson, Lisa

Subjects: GENERIC drugs; UNITED States. Food & Drug Administration; WOODCOCK, JanetUNITED States

• Source: Applied Clinical Trials. Nov2012, Vol. 21 Issue 11, p12-13. 2p.

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Patients, PDUFA, Pandemics to Shape Clinical Research in 2016.

• Authors : Wechsler, Jill

Subjects: UNITED States. Food & Drug Administration; PATIENT participation; DRUG development

• Source: Applied Clinical Trials. Dec2015/Jan2016, Vol. 24 Issue 12, p8-8. 1p.

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FDA Updates Policies to Continue Gains in New Drug Approvals.

• Authors : Wechsler, Jill

Subjects: UNITED States. Food & Drug Administration; DRUG approval laws; WOODCOCK, Janet

• Source: Applied Clinical Trials. Feb/Mar2015, Vol. 24 Issue 2/3, p8-8. 1p.

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FDA, Sponsors Continue Quest for More Efficient Clinical Trials.

• Authors : Wechsler, Jill

Subjects: CLINICAL trial registries; RESEARCH funding; UNITED States. Food & Drug Administration

• Source: Applied Clinical Trials. Feb/Mar2014, Vol. 23 Issue 2/3, p12-12. 1/2p.

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FDA Promotes Quality and Risk Management.

• Authors : Wechsler, Iill

Subjects: UNITED States. Food & Drug Administration; CLINICAL trials; QUALITY

• Source: Applied Clinical Trials. Apr2013, Vol. 22 Issue 4, p12-12. 1p.

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Notes from the FDA.

• Authors : Shapiro, Marissa

Subjects: PERSONNEL management; INDUSTRIAL management; PHARMACEUTICAL industryUNITED States

• Source: Applied Clinical Trials. Nov2008, Vol. 17 Issue 11, p50-50. 1p.

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