FDA advises early engagement and error prevention for BLA submissions, says CBER expert
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A CBER specialist shared practical guidance for companies preparing biologics license applications.
The expert stressed that early interaction with the FDA’s Office of Therapeutic Products can streamline the review.
Applicants should meticulously address potential technical and administrative issues to avoid delays.
Keeping the regulatory project manager informed throughout the process is also recommended.
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This writeup was produced by pharmadog from original reporting by raps.
Original headline: “Recon: FDA approves drugs for Parkinson’s, bile duct cancer, rare soft tissue disease; Merck, Daiichi scrap application for ADC ...”
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