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Antibiotic Development Question: Should A Phage Library Equal One Application?

 
• By Derrick Gingery

FDA may have to take a personalized medicine approach when deciding how to classify a phage bank used to create the treatments.

3d render Bacteriophage viruses infecting bacterial cell
3-D rendering of Bacteriophage viruses infecting bacterial cell

Adaptive Phage Therapeutics is moving toward commercialization of a potentially non-traditional antimicrobial treatment, but has yet to answer a simple, yet very important question.

"That was probably one of my biggest questions when I started Adapted Phage Therapeutics: What's the drug?" company CEO Greg...

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More from Review Pathways

Only One ANDA Was Submitted To The US FDA During The Shutdown; It Should Have Been None

 
• By Derrick Gingery

The FDA told the Pink Sheet an ANDA managed to be submitted during a period when no new ANDAs could be accepted.

India Readies More Regulatory Reform, Globally ‘Aligned’ Biosimilars Guidance

 
• By Anju Ghangurde

India is advancing regulatory rationalization efforts, refining procedures and pathways. Guidelines for biosimilars are expected to align with international standards, while early steps towards PIC/S compliance have been initiated.

Obscure User Fee Provision Gives Generic Drug Sponsors More Time To Pay Fees Post-Shutdown

 
• By Derrick Gingery

ANDA sponsors received 20 days to pay fees associated with applications submitted during the government shutdown, while NDA and BLA sponsors only received five days.

GDUFA IV: US FDA Wants to ‘Streamline’ Formal Meeting Structure

 
• By Derrick Gingery

The FDA proposed changes to the formal meeting system for sponsors in the next generic drug user fee program cycle, in part to speed timelines.

More from Pathways & Standards

GDUFA IV: US FDA Wants to ‘Streamline’ Formal Meeting Structure

 
• By Derrick Gingery

The FDA proposed changes to the formal meeting system for sponsors in the next generic drug user fee program cycle, in part to speed timelines.

Onshoring Incentives Among US FDA’s GDUFA IV Proposals

 
• By Derrick Gingery

During the first GDUFA IV negotiation session, industry representatives were unsure whether the FDA’s idea to create pathways for onshoring incentives fit the scope of the generic drug user fee program.

Eight African Agencies Finalizing Reliance Mechanism To Speed Drug Approvals

 
• By Neena Brizmohun

A new reliance pathway under which regulators will rely on each other’s assessment reports strengthens the goals of key continental health initiatives, including the newly formed African Medicines Agency.