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Latest From Sue Sutter
Final review documents have been posted for only four of 12 biosimilars due to a backlog in applications considered the third priority level for redaction – a categorization that seems out of sync with the agency’s approach to labeling and its emphasis on promoting price competition.
CDER is no longer proactively posting mid- and late-cycle meeting minutes and certain correspondence with sponsors for new drug and biologic approvals; drugs center says it is focused on ensuring the most scientifically meaningful information is prioritized and posted in a timely manner, but some observers say the change raises transparency concerns.
Non-Traditional Antimicrobials Can Follow Regulatory Path Laid By Small Molecule Antibiotics, US FDA Says
Live biotherapeutics, fecal microbiota transplants and bacteriophages may be novel when it comes to fighting hard-to-treat infections, but their development and route to approval may not be all that different than traditional antibiotics, officials from FDA’s drugs and biologics center say.
Degree of rigor may vary depending upon intended use of the data throughout a drug’s lifecycle, stakeholders say in comments on FDA’s first patient-focused drug development draft guidance; industry and advocates push for clarity on interactions to discuss patient experience studies with FDA staff and the promotional implications of such data.
Citing need for more ‘pull’ incentives to overcome commercial hurdles, FDA commissioner says a subscription-based fee reimbursement system would provide a foundation for return on investment of new antimicrobials targeting multi-drug resistant pathogens.
Carve outs highlight growing problem for industry and FDA – the absence of an expedited process for adding or removing biosimilar indications; Celltrion seeks approval for only three of eight indications on label of reference product, Genentech’s Rituxan, due to intellectual property and exclusivity issues.