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REMS Abuse Website: Has It Changed The Behavior Of Innovators?

 
• By Michael Cipriano

Updated numbers from the US FDA's REMS abuse website show that Celgene has received two additional safety determination letters, raising question's about whether the public list has changed the practices of brand companies hindering generic company access to samples.

The Shame
Has FDA been effectively shaming pharma companies? • Source: Grey World

The Association for Accessible Medicines (AAM) has contended that the US FDA's public list of drug companies suspected of using risk evaluation and mitigation strategies (REMS) to stonewall generic developer access to branded samples has done little to change the behavior of innovators. Based to the most recent data posted by the agency, the generic drug trade association may have a point.

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US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 
• By Michael McCaughan

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.

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US FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 
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Japan Pushes Generic Industry Reforms Via New Govt Fund

 
• By Lisa Takagi

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More from Biosimilars & Generics

US FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 
• By Urtė Fultinavičiūtė

The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 
• By Derrick Gingery

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

Biosimilars Industry Celebrates EMA’s Plan to Reduce Clinical Trials

 
• By Dave Wallace

The European Medicines Agency’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam.