Regulatory Oversight and Compliance

A Four-Phased Approach for Evaluating a Quality Risk Management Activity

June 02, 2023

Using the four-phased method to assess QRM can ensure continual improvement and that regulatory requirements are met.

FDA Eyes New Strategies to Spur Gene Therapy Development

June 02, 2023

An increase in applications for gene therapies is putting stress on FDA’s resources.

Governance of Future Pandemics

June 02, 2023

COVID-19 has raised the specter of pandemic planning and the question of what can be done now to prevent future disaster.

EMA Accepts MAAs from Sandoz for Proposed Denosumab Biosimilar

May 31, 2023

Sandoz’s marketing authorization applications for a proposed biosimilar to denosumab are supported by a comprehensive analytical and clinical data package.

FDA Releases Final Guidance on Adjusting for Covariates in Randomized Clinical Trials

May 30, 2023

The guidance describes FDA’s current recommendations regarding adjusting for covariates in statistical analysis of randomized clinical trials.

FDA Eyes Advisory Committee Reform to Enhance Credibility

May 26, 2023

Challenges to approval decisions have prompted FDA officials to reexamine of the role and composition of the agency’s many advisory committees and to explore options for change.

FDA Approves Paxlovid for Treatment of COVID-19 in Adults

May 26, 2023

Paxlovid is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis for prevention of COVID-19.

FDA Approves Topical Gene Therapy for Treating Wounds Associated with Rare Genetic Skin Disorder

May 25, 2023

FDA has approved the first topical gene therapy product for treating wounds in patients with dystrophic epidermolysis bullosa.

FDA Approves AbbVie’s Bispecific Antibody for Treating Lymphoma

May 25, 2023

FDA has approved AbbVie’s EPKINLY (epcoritamab-bysp), a bispecific antibody for treating relapsed or refractory diffuse large B-cell lymphoma.

FDA Approves Blueprint Medicines’ Rare Blood Disorder Treatment

May 24, 2023

Blueprint Medicines’ avapritinib has been approved by FDA for the treatment of indolent systemic mastocytosis.