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BioMarin InvestorRoomBioMarin Files Investigational New Drug
Application for PEG PAL for the Treatment of
PKU
PRNewswireFirstCall
NOVATO, Calif.
BioMarin Pharmaceutical Inc. (Nasdaq and SIX: BORN)
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What is biomarin files investigational new?
Biomarin files investigational new drug applications (INDs) with the FDA to conduct clinical trials on new drugs.
Who is required to file biomarin files investigational new?
Any pharmaceutical company or researcher planning to conduct clinical trials on new drugs must file an IND with the FDA.
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The IND application must include detailed information on the drug's safety, manufacturing, labeling, and proposed clinical trials.
What is the purpose of biomarin files investigational new?
The purpose of filing an IND is to obtain FDA approval to conduct clinical trials on new drugs in humans.
What information must be reported on biomarin files investigational new?
The IND must include information on the drug's chemical composition, manufacturing process, preclinical studies, and proposed clinical trials.
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