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Regulatory Affairs
Drug Approval Process in India
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January 4, 2020
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Clinical Data Management
ECOG Performance Status
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January 3, 2020
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Regulatory Affairs
Orphan Drug Designation in US, EU and Japan
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December 31, 2019
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Latest Pharma-News
AVITA medical receives U.S. FDA investigational device exemption approval of clinical feasibility study in order to evaluate Recell system for Vitiligo
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December 30, 2019
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Regulatory Affairs
The Drug approval process in EU:
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December 29, 2019
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Big Change in FDA process for Biologics:
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December 29, 2019
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U.S. Food and Drug Administration (FDA) approved sNDA to Revise Flexion Therapeutic’s ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) for the treatment of osteoarthritis (OA)...
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December 27, 2019
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Regulatory Affairs
Biologics Approval Pathways in the USA:
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December 27, 2019
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Regulatory Affairs
Generic Products Approval Pathways (USA): Paragraph Certification I, II, III, and IV:
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December 25, 2019
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U.S. Food and Drug Administration (FDA) approved Allergan’s UBRELVY(ubrogepant) for the acute treatment of migraine with or without aura in adults.
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December 25, 2019
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U.S. FDA approves EISAI’S DAYVIGO™ (LEMBOREXANT) for treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adults
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December 25, 2019
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Roche and Sarepta Therapeutics enters licensing agreement in order to improve the lives of patients living with Duchenne muscular dystrophy
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December 24, 2019
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