Biotech Policy track

Biotech Policy

The US regulatory framework, the FDA, gene therapy and CRISPR rules, agricultural biotech, biosecurity, public health law, genetic privacy, and future governance.

8Modules
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BP1
Regulatory Landscape
A single CRISPR-edited mushroom can require approval from three different federal agencies.
BP2
FDA
In 1937, a Tennessee pharmaceutical company released a new liquid formulation of an antibiotic called sulfanilamide.
BP3
Gene Therapy
In December 2023, the FDA approved a drug called CASGEVY.
BP4
Ag Biotech
In 2016, a Pennsylvania State University plant pathologist named Yinong Yang submitted documents to the USDA describing a new mushroom variety.
BP5
Biosecurity
In 2005, researchers at the US Centers for Disease Control and Prevention published a paper in Science describing how they had reconstructed the 1918 influenza virus.
BP6
Public Health Law
In February 1905, the US Supreme Court decided a case called *Jacobson v.
BP7
Privacy & Genetics
In April 2018, police in California arrested a 72-year-old man named Joseph James DeAngelo.
BP8
Future Governance
In 2023, a research group based at Boston University and several other institutions published a paper describing a new SARS-CoV-2 variant they had constructed in the lab — combining the spike protein of Omicron with the genetic backbone of the original Wuhan strain.
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FoundationsGenomicsMarine BiologyBiotech