Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of new approach methodologies, experts told BioSpace, particularly emphasizing ...
Draft recommendations allow skipping at least one U.S.-reference comparative PK study when analytical and other evidence supports biosimilarity, including use of ex-U.S. comparator data in defined ...
Two former US Food and Drug Administration (FDA) officials have commented on and proposed changes to the agency’s recent ...
Several patient and disease advocacy organizations have responded to the Center for Drug Evaluation and Research's (CDER) ...
Reaffirms guidance to resubmit the Anaphylm NDA in Q3 2026Received clarifying feedback from the FDA on pharmacokinetic (PK) and human factor (HF) ...
Pharmaceutical regulatory consulting for drug developers and CROs: IND CMC, method validation, NDA strategy, and FDA ...
ALEXANDRIA, VA ProcellaRX, LLC today released “The Reinvention Lab: A Vision for the Future of Digital Validation 2030,” ...
Macrae reported that the rolling submission of a BLA to the FDA for ST-920, Sangamo's first wholly owned BLA, is in progress. Sangamo has also transitioned to a clinical stage neurology company, ...
FDA guidance unlocks an estimated $50 billion total addressable market, allowing companies to lawfully transition the 70% illicit flavored vape market into a compliant ecosystem Ispire's 40%-owned IKE ...
"As CMS Launches its $500 Cannabinoid "Engagement Incentive," MMJ International Holdings Warns of a Regulatory "Double ...
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