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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

This article aims to provide a comprehensive overview of the key aspects of the regulatory framework, highlighting the requirements and challenges faced by pharmaceutical companies seeking to introduce generic drugs into the Japanese market. New Drug Application (NDA) : Needed for marketing approval of new drugs.

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The rising impact of biomarkers in early clinical development

Drug Target Review

Prior to being validated, the FDA will still consider biomarkers in the marketing approval process as a reasonably likely surrogate endpoint or candidate surrogate endpoint. Clinical Pharmacology and Therapeutics. Clinical Pharmacology and Therapeutics. Rodrigues AD. 113:9861002.

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Vamorolone

New Drug Approvals

11] [21] [22] In October 2023, the Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Agamree, intended for the treatment of Duchenne muscular dystrophy. [2] This article incorporates text from this source, which is in the public domain.

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Antibody Drug Conjugates: windows of opportunity

Drug Target Review

However, ADCs are a nascent therapeutic option and real-world clinical data is emerging daily that is shedding light on the utility and potential of this exciting modality to deliver against its promise. The global ADC market is expected to continue this steep upward trajectory and is anticipated to exceed $16 Billion by 2026.

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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine.

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Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Agency IQ

Title Type Comments Close Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564 Draft Guidance July 5 Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency Draft Guidance July 5 Financial Transparency and Efficiency of the Prescription (..)

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Article FDA Thank You In new contract notices, FDA seeks help on user fee commitments and moving opioid, oncology priorities forward

Agency IQ

For example, a letter from Massachusetts Senator Ed Markey called on FDA to “enhance post-market surveillance of opioids, including by conducting regular, formal reviews of opioid approvals,” among other regulatory activities. Read AgencyIQ’s backgrounder on the FDA’s recent responses to the opioid crisis here. ].

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