US FDA 'Medical Innovation Development Plan' Outlined By Gottlieb

Testifying before Senate subcommittee, FDA commissioner put his plans for facilitating new drug development front and center, a shift from his many past discussions about generic drug development.

FDA entrance sign 2016

The US FDA will be releasing in the next six months a guidance on the clinical evaluation of targeted therapies for rare disease subsets as part of a broader "medical innovation development plan"designed to facilitate the development of breakthrough new treatments, agency Commissioner Scott Gottlieb announced.

Testifying June 20 before the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies, Gottlieb...

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 Approval Standards

Generic Drugs And AI: Maximum Daily Dose Tool Could Help US FDA Be ‘At The Forefront’

 

The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.

UK Approves Biogen’s Qalsody After England Revises Reimbursement Approach

 

Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.

Danish Medicines Agency Wants Companies To Use “Better Data Format” To Submit Bioequivalence Studies

 

The Danish Medicines Agency is requesting that data from bioequivalence studies to be submitted in the CDISC format in addition to the current eCTD format. It believes the move will make it easier for the agency claims to access and analyze data and will reduce the burden for applicants.

Real-Time Release Of CRLs Is US FDA’s Goal, Agency Leaders Affirm

 

The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.

More from Pathways & Standards

Mexico Speeds Up Market Access With Regulatory Reliance Guidelines

 

Mexico’s drugs regulator will be able to grant quicker drug approvals based on decisions issued by World Health Organization listed authorities and founding ICH members.

UK Approves Biogen’s Qalsody After England Revises Reimbursement Approach

 

Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.

Danish Medicines Agency Wants Companies To Use “Better Data Format” To Submit Bioequivalence Studies

 

The Danish Medicines Agency is requesting that data from bioequivalence studies to be submitted in the CDISC format in addition to the current eCTD format. It believes the move will make it easier for the agency claims to access and analyze data and will reduce the burden for applicants.