As US FDA Shutdown Continues, What Will Be The Cost Of Not Spending?

Bolus of applications could be filed once government reopens, but employee morale and recruitment efforts could suffer drop-off.

Close-up of little On/Off switch with soft blurred background - Image

The partial shutdown of the US FDA that began Dec. 21 seems destined to continue at least a while longer, leaving sponsors unable to file applications and the agency unable to conduct inspections, among other stoppages.

The so-called "lapse period" (the second in 2018) began after Congress failed to pass an appropriations bill for FDA and some other parts of the government following a confrontation between

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Product Reviews

More from Pink Sheet

EU Shaping Biotech Act To Unleash SME Potential

 

European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.

New EU Filings

 

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
• By 

Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.