FDA Would Establish Conditions for Swift Manufacturing Changes

FDA draft 'conditions established' guidance proposes to smooth the way for continual improvement of manufacturing processes for drugs and biologics by saying which manufacturing changes don't need to be reported.

Companies may be more likely to continually improve the way they make drugs and biologics now that FDA has clarified in a May 29 draft guidance that it will only review and inspect for changes to the conditions established in approved applications and licenses.

By defining such established conditions, the draft guidance clarifies which changes are so minor that companies should manage them with...

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 United States

How Could MFN Pricing Impact Commercial Market?

 
• By 

Industry experts forecast the impact of President Trump's Most-Favored Nation drug pricing policy on the commercial insurance industry.

COVID-19 mRNA Vaccine Labels Now Quantify Myocarditis Risk, But ACIP Wants Other Changes

 
• By 

New members of the CDC’s Advisory Committee on Immunization Practices suggested concerns beyond myocarditis, questioning whether test-negative observational studies are giving an incorrect picture of effectiveness.

Medicare’s Combo Products Negotiation Plan Conflicts With US FDA Standards, Firms Argue

 
• By 

The plan could curtail a period of pricing flexibility for newer subcutaneous versions of important oncology drugs.

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.

More from North America

Trump Administration Closer to Unprecedented Drug Price Transparency Requirements

 
• By 

New rules requiring more granular drug pricing data to be disclosed in machine-readable files will go into effect in 2026.

Orphan Drug Relief Still In Budget Bill But Uncertainty Remains

 
• By 

The budget reconciliation bill nears final passage without pharmacy benefit manager reforms or provisions that would facilitate access to cell and gene therapies for children, but its Medicaid cuts pose a significant threat to prescription drug access.

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.