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Regulatory Affairs

Drug Approval Process in India

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Clinical Data Management

ECOG Performance Status

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Regulatory Affairs

Orphan Drug Designation in US, EU and Japan

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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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Regulatory Affairs

The Drug approval process in EU:

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Other

Big Change in FDA process for Biologics:

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Latest Pharma-News

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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Regulatory Affairs

Biologics Approval Pathways in the USA:

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Regulatory Affairs

Generic Products Approval Pathways (USA): Paragraph Certification I, II, III, and IV:

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Latest Pharma-News

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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Latest Pharma-News

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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Latest Pharma-News

Roche and Sarepta Therapeutics enters licensing agreement in order to improve the lives of patients living with Duchenne muscular dystrophy

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