FDA Hiring Campaign Continues; Goal Is Addressing Pending ANDAs

GDUFA funding will bring 50 additional people to the Office of Pharmaceutical Quality for generic drug review purposes.

FDA entrance sign 2016

FDA is continuing its hiring surge to gain a handle on the large basket of ANDAs it has pending.

The agency is adding another 50 people to help with the generic drug review process, Center for Drug Evaluation and Research Director Janet Woodcock told the Senate Appropriations Agriculture, Rural...

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 Pricing Debate

US ‘Most Favored Nations’ Drug Pricing Policy Will Jeopardize Innovation In Europe

 

The US MFN executive order is the latest in a series of concerning US developments that are contributing to uncertainty for the European pharmaceutical industry, according to France Biotech’s vice president, Alexandre Regniault.

Japan Price Cuts For Epkinly and Lunsumio Following CEA

 
• By 

Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.

GLP-1 Pricing ‘Paradigm Shift’ Possible, But Would It Meet Trump’s MFN Goals?

 
• By 

For the Trump Administration, the blockbuster GLP-1 drugs for obesity have become a poster child for the disparity between US and foreign prices.

Could EU Collective Procurement Counter US Most Favored Nation Policy?

 

Joint procurement, if used by member states to respond to potential pricing and access challenges caused by a US most favored nations pricing policy, would cause more uncertainty for pharmaceutical companies, warn industry representatives.

More from Market Access

Rocky Rollout Spells Trouble for Medicare Prescription Payment Plan

 

Enrollment in the new Medicare Prescription Payment Plan was lower than expected in the first year and well below CMS expectations, and invoicing data indicates members are slow to pay.

PBM Investigation, Enforcement Action ‘Critical Priorities’ At FTC, Chair Says

 
• By 

The new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.

US FDA’s Familiar Drug Pricing To-Do List

 

President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.