Blog | HemaCare

FDA Policy Changes will Accelerate Cell and Gene Therapy Approvals

Feb 21, 2019 10:02:00 AM / by Nancy Andon, MSc posted in FDA, gene therapy, GMP, cell therapy, gmp-compliant

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The U.S. Food and Drug Administration (FDA) has announced that they are adding staff and rolling out policy changes aimed at advancing the development of safe and effective cell and gene therapies. [1] The announcement came in the form of a press release on January 15th, citing that the new policies are a response to the current surge in cell and gene therapy products that the agency is handling. Based on the number of investigational new drug (IND) applications being submitted, the FDA projects a significant rise in the number of therapies that will be approved over the next few years:

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FDA Provides Guidance for Early Stage Trials of Gene and Cellular Therapy

Jul 15, 2015 1:00:47 PM / by Maria posted in FDA, clinical trials, research, Stem Cell Therapy, stem cells

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Gene and cellular therapy is different from the drugs that have come before -- and so are the dangers. Guidance from the FDA is available to avoid pitfalls.

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FDA Provides Support for Mesenchymal Stem Cells as Therapeutics

Oct 29, 2014 1:00:02 PM / by Daisy posted in FDA, CBER, clinical trials, research

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The FDA has an agency that provides researchers with assistance towards taking mesenchymal stem cells to clinical trials and approvals.

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Fine-Tuning Therapeutic Mesenchymal Stem Cells

Jul 23, 2014 1:00:09 PM / by Daisy posted in FDA, CBER, Dendritic cells, immunomodulation, stem cells, T cells

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Expiration Date for Cord Blood Units in Storage

Jun 23, 2014 1:00:54 PM / by Daisy posted in FDA, cryopreservation, neutrophil, platelet recovery, research, stem cells

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