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PDUFA VII Communications: Earlier PMR Talks, Formal Meeting Additions

 
• By Derrick Gingery

Sponsors will receive additional agency interactions through the formal meeting process, as well as an option to ask clarifying questions later.

Turning clock back
During PDUFA VII, sponsors should learn earlier in the assessment period that a postmarketing requirement may be necessary. • Source: Alamy

Most new drug applicants will receive an earlier warning that postmarketing requirements are necessary upon approval during the next prescription drug user fee program cycle.

A common industry complaint is that often postmarket requirements (PMRs) are hurriedly agreed to at the end of an application...

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Kisunla Back In The Spotlight As EMA Reconsiders Alzheimer’s Drug Rejection

 
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