Pink Sheet is part of the Business Intelligence Division 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
UsernamePublicRestriction

Antibiotic Development: Limited Population Pathway In US Removes Barrier

Executive Summary

Allergan's Avycaz could be indicator of how FDA will use the 21st Century Cure's new approval mechanism; experts maintain the provision does not lower FDA's standards of safety.

Advertisement

Related Content

Amplyx Raises $67m For Antifungals Against Life-Threatening Pathogens
AMR Roundtable: The Push And Pull Of Antimicrobial Development Incentives (Part 1)
Antibiotic Spring? Regulatory Incentives Spur Activity – And Maybe Medical Advances
Antibiotics Pipeline Is Lively, But Sponsors Are Fragile
Cempra's Solithera Draws FDA Complete Response Letter On Liver Risks
Rx For Industry: Key Provisions Of The 21st Century Cures Act
Antibiotic Development: ‘Wildcard Exclusivity’ Proposal Returns
Cempra’s Antibiotic Likely Needs Bigger Trial – But Might Be Able To Do It In Phase IV
Actavis Avycaz Approval Shows How FDA Handles Limited-Data, Limited-Use Antibiotic
FDA Worries About Off-Label Use, Stewardship With Limited-Population Approval Pathway

Topics

Related Companies

Related Deals

Advertisement
UsernamePublicRestriction

Register

PS119928

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

All set! This Question has been sent to 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