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Generic User Fee Renewal Talks Faced 'Buyer's Remorse' From GDUFA I

 
• By Sue Sutter

Industry dismay at slow pace of ANDA approvals and FDA communications in early years of first user fee agreement factored into GDUFA II negotiations.

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Participants in negotiations to renew the generic drug user fee agreement had to overcome industry's "buyer's remorse" following complaints about FDA's early implementation of ANDA approval and communication provisions in the first Generic Drug User Fee Act (GDUFA I) program.

At the same time, negotiators had to address FDA's logistical limitations and concerns about the quality of initial ANDA submissions,...

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ANDA User Fees: Complex Generics, Transparency, Communications Are Early Negotiation Targets

 
• By Sue Sutter

Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.

US FDA Will Not Pull Teva And MSN Hetlioz ANDAs, Rejects Vanda Citizen Petitions

 
• By Dean Rudge

The FDA concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements and there was no “mistake” or untrue statement in the original ANDA approvals.

US Supreme Court Wants Solicitor General Input On Hikma Skinny Label Case

 
• By Dean Rudge

The US Supreme Court is seeking the administration's view following the Federal Circuit decided to reopen Amarin’s case against the ‘skinny-label’ generic Vascepa (icosapent ethyl).

Lupin Concedes To Harmony On Generic Wakix With 2030 Launch Agreement

 
• By Dean Rudge

Lupin became the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster.

More from Biosimilars & Generics

US Supreme Court Wants Solicitor General Input On Hikma Skinny Label Case

 
• By Dean Rudge

The US Supreme Court is seeking the administration's view following the Federal Circuit decided to reopen Amarin’s case against the ‘skinny-label’ generic Vascepa (icosapent ethyl).

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

 
• By Eliza Slawther

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.

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 
• By Neena Brizmohun

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.