1. Pink Sheet
  2. >>Rare Diseases

CBER’s Goal To Reach Normal Ops In 2023 Includes Clearing IND, Meeting Backlogs In 2022

 
• By Derrick Gingery

CBER director Peter Marks also wants to work on rare disease gene therapy issues and increase hiring before the end of the year.

backlog and stacks of paper
CBER wants to reduce the IND backlog in its Office of Vaccines Research and Review before the start of 2023. • Source: Shutterstock

The return to normal operations within the US Food and Drug Administration'sCenter for Biologics Evaluation and Research next year will require eliminating backlogs and resuming regular meeting schedules.

CBER director Peter Marks said the center’s theme for the remainder of 2022 is response and recovery as it tries...

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 Rare Diseases

More from Pink Sheet

EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 
• By Neena Brizmohun

While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.

EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 Others

 
• By Eliza Slawther

Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.

BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.