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© 2023 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2023 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
June 08, 2023
The document builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies.
June 05, 2023
Reimbursement for Alzheimer's medicines still will occur only with the completion of studies to support full FDA approval.
FDA has published a new system for providing basic and essential information on patient use of drugs and certain biologic products.
June 02, 2023
An increase in applications for gene therapies is putting stress on FDA’s resources.
COVID-19 has raised the specter of pandemic planning and the question of what can be done now to prevent future disaster.
May 31, 2023
Sandoz’s marketing authorization applications for a proposed biosimilar to denosumab are supported by a comprehensive analytical and clinical data package.
May 30, 2023
The guidance describes FDA’s current recommendations regarding adjusting for covariates in statistical analysis of randomized clinical trials.
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.
Paxlovid is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis for prevention of COVID-19.
May 25, 2023
FDA has approved the first topical gene therapy product for treating wounds in patients with dystrophic epidermolysis bullosa.