1. Pink Sheet
  2. >>Product Reviews

US FDA Not Missing Assessment Goals, But Guidance Reminds That It’s Possible

 
• By Derrick Gingery

New Q&A guidance also states that its near-term focus for resources will be on coronavirus and some other conditions.

FDA Approved typed words on a vintage typewriter
Guidance addresses potential for user fee goal misses and virtual advisory committee meetings. • Source: Shutterstock

US Food and Drug Administration staff continue to meet user fee goal dates for product reviews, but stakeholders worry that delays are imminent given the substantial agency resources now devoted to the coronavirus pandemic.

Multiple sponsors and others agree with the FDA's statement that application decision goals remain on track. But stakeholders seem to...

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 Product Reviews

Repurposed Generics For Rare Diseases: Janet Woodcock Proposes Shortcut

 
• By Grace Moser

A Duke-Margolis working group is developing ideas to enable non-profit firms to seek US FDA approval for new indications for off-patent medicines. The former acting commissioner thinks citizen petitions might be the fastest route.

NDA User Fees Will Grow 8.6% Next Year As FDA Projects More Applications But Fewer Sponsor Meetings

 
• By Nielsen Hobbs and Derrick Gingery

The ups – and some downs – of the US FDA’s prescription, biosimilar, and generic user fees for FY 2026 are tabulated by the Pink Sheet.

EU 2025 Novel Drug Approvals See Conditional Authorizations Outpacing Previous Years

 
• By Neena Brizmohun

The six EU conditional marketing authorizations granted in the first half of 2025 alone equal the full count for 2024 and come close to the annual totals for the previous two years. Meanwhile, 1H 2025 saw a 30% rise in new active substance approvals compared to the same period last year.

New EU Drug Safety Rules Scrap Signal Detection Pilot, Boost Audit & Subcontracting Controls

 
• By Vibha Sharma

The European Commission has adopted new rules to cut red tape in pharmacovigilance, tighten oversight of outsourced drug safety activities, and ensure a balanced approach to signal detection, boosting both efficiency and patient safety.

More from Pink Sheet

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

 
• By Anabel Costa-Ferreira

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.

England’s NICE Hunts For New Chief As Sam Roberts Prepares To Step Down

 
• By Eliza Slawther

Sam Roberts, chief executive of the health technology assessment institute, NICE, will step down from her role at the end of the year. The agency is now on the lookout for a new leader, who will be the fourth in its history.

NDA User Fees Will Grow 8.6% Next Year As FDA Projects More Applications But Fewer Sponsor Meetings

 
• By Nielsen Hobbs and Derrick Gingery

The ups – and some downs – of the US FDA’s prescription, biosimilar, and generic user fees for FY 2026 are tabulated by the Pink Sheet.