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Yearly Archives: 2019

Orphan Drug Designation in US, EU and Japan

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Orphan Drug Designation in USA: There are two routes (criteria) for obtaining orphan designation of a drug and biologics for a rare disease or condition.Orphan...

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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Dec 30, 2019: AVITA Medical Limited announced that the U.S. FDA has approved the company’s Investigational Device Exemption (IDE) application to conduct a feasibility...

The Drug approval process in EU:

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50 regulatory authorities from the 31 European Economic Area (EEA) countries (28 EU Member States, including Iceland, Liechtenstein and Norway), the European Commission and EMA creates...

Big Change in FDA process for Biologics:

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 “The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) requires that a marketing application for a “biological product” (that previously could have...

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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Dec. 26, 2019: Flexion Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) to revise...

Biologics Approval Pathways in the USA:

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Existing Regulatory framework for biologics approval in the US: Two laws were enacted to regulate drugs in the USA: The Federal Food, Drug, and Cosmetic...

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

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Few facts before discussing about generic products approval in US: Hatch-Waxman Act: The Drug Price Competition and Patent Term Restoration Act is commonly...

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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Dec. 23, 2019: U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for Allergan’s UBRELVY™ (ubrogepant) for the acute treatment of...

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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Dec 23, 2019: Eisai Co. announced that the U.S. Food and Drug Administration (FDA) approved the New Drug Application for its in-house discovered and...

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

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Dec 23, 2019: Roche and Sarepta Therapeutics announced the signing of a licensing agreement providing Roche exclusive commercial rights to SRP-9001 (AAVrh74.MHCK7.micro-dystrophin),  Sarepta’s investigational...

FibroGen Submits New Drug Application to the U.S. FDA for Roxadustat for the treatment of anemia of chronic kidney disease (CKD)

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Dec. 23, 2019: FibroGen announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for roxadustat for...

U.S. Food and Drug Administration(FDA) approved Intra-Cellular Therapie’s Novel Antipsychotic CAPLYTA® (lumateperone) for the treatment of schizophrenia in adults

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Dec. 23, 2019 : U.S. Food and Drug Administration(FDA) approved Intra-Cellular Therapie’s CAPLYTA® (lumateperone) for the treatment of schizophrenia in adults, commercial launch of CAPLYTA in...
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