FDA To Announce Guidelines for Early Stages of Drug Development
FDA as early as Thursday is expected to announce new guidelines for the early stages of drug development, including eased restrictions on the production of small batches of experimental drugs and modified regulations for the number of animal studies required before certain drugs are tested in humans, the Wall Street Journal reports. The guidelines are intended to improve the new drug pipeline and help pharmaceutical companies and academic researchers "get better information about [new products] at the beginning of the development process," according to the Journal.
One aspect of the new guidelines will affect manufacturing standards for the production of small batches of experimental drugs in a laboratory or similar setting. For example, FDA is expected to loosen some restrictions on drug production that can be difficult for academic researchers to meet, such as the current requirement that each raw ingredient of a drug must be stored in a different room or that a separate laboratory must be maintained for the sole purpose of confirming quality measures.
According to the Journal, the new guidelines might still require the separation of certain ingredients but could allow the ingredients to be stored in the same room.
The new guidelines also are expected to address restrictions on exploratory studies. Under current guidelines, companies must complete extensive testing of experimental products in animals before applying to FDA for permission to test the drugs in humans. The new guidelines would decrease some requirements for the amount of animal testing required before companies can apply to test a drug in humans.
According to the Journal, the lessened requirements for animal testing would only apply in certain cases where the human testing would be "very limited -- likely seven days at most, in a small number of people -- and the agency would scale the testing requirements to the potential risk of the human studies." The new guidelines for exploratory testing are aimed at allowing drug makers to assess a drug's "pharmacokinetics," meaning how the drug behaves in the human body.
Studies examining a drug's effectiveness still will be subject to existing guidelines (Wilde Matthews/Winslow, Wall Street Journal, 1/12).