Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

BARDA Official Worries About How Non-Traditional Antibiotics Will Get To Market

Executive Summary

Promising non-traditional antibiotic therapies need a clear path to market to entice investment, US Biomedical Advanced Research and Development Authority official says.

You may also be interested in...



Everything's Special At US FDA: Priority NDA/BLA Filings Surge

The FY 2018 PDUFA performance report also indicates that applications with standard assessments fell compared to long-term averages.

LPAD Approval Pathway Is Not Saving Antimicrobial Development

US FDA and CMS explore reimbursement ideas to strengthen business case for antimicrobial development; new approval pathway likely is only needed in special situations.

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.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS123327

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel