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June 23, 2023
The guidance describes the CDER formal dispute resolution (FDR) procedures for eligible requestors or sponsors that wish to appeal a scientific and/or medical issue related to a final order.
June 21, 2023
The new guidelines contain formulation recommendations for vaccines launching in autumn 2023.
FDA’s new voluntary pilot program is designed to help clinicians select appropriate cancer treatments for patients.
June 16, 2023
There is concern that debates will delay the five-year reauthorization of PEPFAR under review by Congress.
June 08, 2023
The complaint alleges that Medicaid price controls implemented in the Inflation Reduction Act will negatively impact biopharmaceutical innovation.
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
What implications will EMA’s recent regulatory reform have on pharma?
An increase in applications for gene therapies is putting stress on FDA’s resources.