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Antibiotics Stewardship Remains Open Question On Capitol Hill

 
• By Cathy Dombrowski

FDA’s role in the practice of medicine becomes an issue as IDSA’s proposal to spur antibiotic development by coupling small trials with limited use comes late to the antibiotic incentives debate on Capitol Hill.

FDA’s role in the practice of medicine could be an issue as Congress debates incentives for antibiotic development as part of legislation to reauthorize the Prescription Drug User Fee Act.

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How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 
• By Joseph Haas and Nielsen Hobbs

With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.

US FDA Not Industry’s ‘Sock Puppet,’ Ultragenyx’s Emil Kakkis Says

 
• By Sue Sutter

The biotech CEO said the Trump Administration’s treatment of FDA employees, including the HHS secretary’s comments about industry capture, are insulting to agency staff, but he is encouraged by FDA Commissioner Martin Makary’s talk of a new conditional approval pathway.

US FDA Asks Adcomm If Opioid Postmarketing Studies Are Relevant, Warrant Action

 
• By Sue Sutter

Two US FDA advisory committees will discuss results from epidemiological studies that attempted to quantify the prevalence, incidence and risk factors for misuse, abuse, overdose and death with opioid analgesics.