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As US FDA Settles Into Teleworking, Will Application Reviews Be Affected?

 
• By Derrick Gingery

Productivity may suffer under coronavirus-mandated telework despite workforce diligence, experts say.

Does your office look like this for the foreseeable future thanks to coronavirus? • Source: Derrick Gingery

Today, like millions of Americans, US Food and Drug Administration assessors are sitting at desks or dining room tables in their homes and opening laptops.

They sip coffee as they log into the FDA servers and access the electronic document room, the agency’s repository of clinical, inspection or other information about pending new or

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EU Pharma Reform: Exclusivity Vouchers Alone Are Insufficient Incentive For Antimicrobials, Industry Says

 
• By Eliza Slawther

European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.

Trump Administration Push For Dismissal, Transfer Of Mifepristone Case Leaves Overhang For Pharma

 
• By Sarah Karlin-Smith

The Trump Administration requested a dismissal or transfer of a lawsuit seeking to tighten the safety requirements for the abortion pill mifepristone on procedural grounds, which still leaves the administration's position on the case's merits unclear.

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
• By Sue Sutter

Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.