Approval Standards


US FDA’s ADHD Drug Relabeling Advances A MAHA Priority, Reviving Data Dispute

 

Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.

How Will Regulatory Filing Winds Blow Globally For Elevidys Following Patient Deaths?

 

Roche’s filing for Elevidys in the EU followed applications in Middle Eastern countries because those markets accept applications based on approval by the US Food and Drugs Administration.

Early Support For EMA’s Trial Of US-Style Standards In Non-Clinical Reviews

 
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An ongoing proof-of-concept study by the European Medicines Agency testing the use of US-style standards for submitting non-clinical raw data in marketing applications has received positive feedback from both industry and regulatory assessors so far.

New EU Approvals

 

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Tepezza, Amgen's treatment for moderate to severe thyroid eye disease.

Review Pathways


Kennedy Appears Ill-Informed On Major Pharma Priorities, Creating Unique Lobbying Dynamics

 

The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.

How Will Regulatory Filing Winds Blow Globally For Elevidys Following Patient Deaths?

 

Roche’s filing for Elevidys in the EU followed applications in Middle Eastern countries because those markets accept applications based on approval by the US Food and Drugs Administration.

Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 

Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

Engage With HTA Body NICE Before Submitting MAA, UK Govt Tells Companies

 

The government has explained how to navigate the UK’s regulatory and market access funding mechanisms.

User Fees


America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US

PDUFA VIII: Cutting Perceived Conflict Of Interest May Be A Theme

 

Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.

US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 

FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
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The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.