1. Pink Sheet
  2. >>Compliance

FDA Guidance Addresses Self-Identification, Facility Payments Under GDUFA

 
• By Joanne S. Eglovitch

An FDA guidance addresses which types of facilities must self-report under GDUFA and pay the facility fee and which facilities must just self-report. Guide also covers whether two separate locations of the same company have to pay a user fee.

FDA issued guidance in a question-and-answer format on July 25 that addresses which types of generic drug manufacturers must self-report under the Generic Drug User Fee Act and pay facility fees, and which facilities need only self-report. The guidance also addresses what is considered a “fatal flaw” that can terminate inspections of generic drug facilities.

The document is titled “Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self-Identification of Facilities, Review...

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 Compliance

Malaysia Clarifies Drug Shortage Reporting Rules & Penalties For Non-Compliance

 
• By Neena Brizmohun

New guidance from the National Pharmaceutical Regulatory Agency responds to the medicines shortages crisis that Malaysia experienced a few years ago.

GDPR Clarity For Pharma: Industry Code Nears EU-Wide Approval After Six-Year Journey

 
• By Vibha Sharma

The pharmaceutical industry is edging closer to EU-wide clarity on how the bloc’s data privacy rules can be applied consistently to clinical trials and pharmacovigilance activities.

Danish Probe Could Influence Rethink Of Controversial EU Urban Wastewater Rules

 
• By Francesca Bruce

Some medicines may be subject to price rises that make them unaffordable if the burden of paying for extra wastewater treatment is not more fairly distributed across different industries, the Danish pharmaceutical industry association has warned.

With Thyroid Petition Win, AbbVie Snares Itself; US FDA Sets Up Another Compounding Fight

 
• By Manas Mishra

AbbVie didn’t get everything it sought from a citizen petition but may still have the upper hand over smaller rivals after FDA gives makers of animal-derived thyroid medications a year to seek approval. If the agency removes compounded products, it could face more pricing pushback.

More from Pink Sheet

Lilly’s Price Deal For Mounjaro In UK A Harbinger Of The MFN Future?

 
• By Cathy Kelly

The arrangement, which implies a behind the scenes negotiated discount, may signal a trend toward less price transparency in foreign markets as manufacturers parry Trump’s Most Favored Nation price demands.

GDPR Clarity For Pharma: Industry Code Nears EU-Wide Approval After Six-Year Journey

 
• By Vibha Sharma

The pharmaceutical industry is edging closer to EU-wide clarity on how the bloc’s data privacy rules can be applied consistently to clinical trials and pharmacovigilance activities.

UK Initiative Steps Up Efforts To Tackle Recruitment Bottlenecks In Dementia Trials

 
• By Anabel Costa-Ferreira

A government-backed program is working on improving the ability to run dementia clinical trials in the UK, and access to trials for participants.