1. Pink Sheet
  2. >>Market Access
  3. >>Pricing Debate

FDA Hiring Campaign Continues; Goal Is Addressing Pending ANDAs

 
• By Derrick Gingery

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
Start Free Trial

Already a subscriber?

More from Pricing Debate

Japan Price Cuts For Epkinly and Lunsumio Following CEA

 
• By Lisa Takagi

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.

Could EU Collective Procurement Counter US Most Favored Nation Policy?

 
• By Francesca Bruce

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.

US FDA’s Familiar Drug Pricing To-Do List

 
• By Michael McCaughan

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.

US Most Favored Nations Policy: Higher Drug Spending In Germany Is ‘Difficult To Imagine’

 
• By Francesca Bruce

Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.

More from Market Access

Why Hympavzi Secured English Funding For Hemophilia B But Not Hemophilia A

 
• By Neena Brizmohun

Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.

US Most Favored Nations Policy: Higher Drug Spending In Germany Is ‘Difficult To Imagine’

 
• By Francesca Bruce

Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.

Japan Reimburses 11 New Drugs But Slashes Price Of Others By Up To 20%

 
• By Lisa Takagi

Japan's NHI program continues to give and take as 11 new drugs are granted reimbursement, while the prices of others - including three ophthalmic therapies - are cut by up to 20% under a Market Expansion Repricing scheme.