NIH Director's Blog: Drug Development

MARCH 11, 2014

Credit: Jane Ades, National Human Genome Research Institute, NIH Type 2 diabetes (T2D) tends to run in families, and over the last five years the application of genomic technologies has led to discovery of more than 60 specific DNA variants that contribute to risk. Plenge RM, Scolnick EM, Altshuler D. Nat Rev Drug Discov.

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Agency IQ

APRIL 12, 2024

Draft guidance on potency assays for CGT products garners extensive stakeholder input Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. As a result, the 2011 guidance was generally seen as basic and outdated.

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Agency IQ

MARCH 29, 2024

Similarly, the Group I and II Polymers and Resins NESHAP were most recently updated when the agency conducted its RTR on December 16, 2008, and April 21, 2011. The HON standards were most recently updated when the agency conducted a residual risk and technology review (RTR) on December 21, 2006.

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Codon

JUNE 26, 2023

DNA sequences are designed on a computer, and it takes a dozen or more clicks to change a single nucleotide. DNA sequences are also checked by hand, so it’s easy to make a mistake. The tool outputs a DNA sequence that encodes all the required enzymes. Anyone who has tried to engineer a cell knows how tedious it can be.

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DNA Therapies Engineering Clinical Trials 52

Codon

JUNE 26, 2023

DNA sequences are designed on a computer, and it takes a dozen or more clicks to change a single nucleotide. DNA sequences are also checked by hand, so it’s easy to make a mistake. The tool outputs a DNA sequence that encodes all the required enzymes. Anyone who has tried to engineer a cell knows how tedious it can be.

DNA 52

DNA Therapies Engineering Clinical Trials 52

Drug & Device Law

DECEMBER 19, 2022

604, 620 (2011) (“The question for ‘impossibility’ is whether the private party could independently do under federal law what state law requires of it.”). one HDPE resin to another HDPE resin) of a packaging component that may affect the impurity profile of the drug product. See PLIVA, Inc. Mensing , 564 U.S.

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