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Antibiotic Development: US FDA Needs Draft Guidance On QIDP Designation, GAO Says

 
• By Brenda Sandburg

Sponsors lack comprehensive advice on how to access benefits of GAIN legislation's incentives, which include the opportunity for fast track designation, priority review designation and five years of market exclusivity, government watchdog says.

Antibiotic resistant bacteria closeup biofilm

After reviewing the actions the US FDA has taken to encourage development of new antibiotics over the last four years, the US Government Accountability Office (GAO) concluded that the agency should issue specific guidance on its qualified infectious disease product (QIDP) designation.

In a report, GAO also recommends that the agency clarify how drug sponsors should use draft guidance documents for antibiotic development. It says drug sponsors are uncertain how...

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Drug, Biologic Policy Staff Return To US FDA, As RIF Process Hangs In Legal Limbo

 
• By Sarah Karlin-Smith

The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.

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• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

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US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
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US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

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More from Agency Leadership

US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

EMA Says Digital Transformation A ‘Fundamental Shift’ In Meeting Regulatory Challenges

 
• By Eliza Slawther

Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.

US FDA Makary’s Pharma CEO Tour Goes Against Transparency Rhetoric

 
• By Sarah Karlin-Smith

FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.