FDA Law Blog: Drug Discovery

SEPTEMBER 27, 2023

The meeting package for Type D meetings should be included with the meeting request. FDA intends to provide preliminary responses to Type D meeting packages no later than 5 calendar days before the meeting date. The goal for meeting minutes is the same as all other meeting types – 30 days after the meeting.

FDA 64

FDA Packaging Animal Testing Production 64

Codon

MARCH 14, 2023

Mice raised at five different animal facilities in Europe, under otherwise identical conditions , have “persistent differences in body weight” and behavior. There are even differences in how their genomic DNA is packaged inside of neurons. Each animal had a different microbiome. Nobody really knows why.

DNA 52

DNA Laboratories Engineering Animal Testing 52

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

The draft guidance recommends that no more than 15 questions are included in the briefing package. CBER will not commit to reviewing packages greater than 250 pages. However, as we noted above, the CMC topics covered in this draft guidance will be covered in Part 2 of this blog coverage.

Therapies 59

Therapies FDA Production Disease 59

Codon

JUNE 2, 2024

At that time, even though animal breeders had long exploited regularities in the patterns of inheritance, the principles underlying heredity remained mysterious. That is—until the Austrian monk Gregor Mendel showed that traits are passed from parent to offspring in discrete, independently assorted packages.

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Laboratories Research Disease Science 128