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December 28, 2015
The FDA program that encourages biopharma companies to develop new treatments for rare and neglected diseases has been in the spotlight recently.
December 17, 2015
The agency has published draft guidance on safety assessment for investigational new drug application safety reporting.
Janet Woodcock, director of the Center for Drug Evaluation, highlights FDA's priority list for 2016.
The agency has launched a new web platform to foster scientific innovation.
December 14, 2015
The use of drug compounding facilities to produce over-priced generic drugs raises quality and regulatory questions.
December 10, 2015
FDA warns the industry of possible contamination in the API baclofen from Taizhou Xinyou Pharmaceutical & Chemical Co., Limited.
EMA Executive Director Guido Rasi outlines his plan for the agency, including a focus on R&D.
December 07, 2015
While stakeholders generally welcome improvements to quality initiatives, they are concerned with how the new requirements will be implemented for more complicated supply-chain models.
December 04, 2015
The agency publishes draft guidance on best practices for communication between FDA and IND sponsors during drug development.
November 30, 2015
The agency promotes safer use of drugs and prevention of medication errors through a new webpage and practice guide.