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FDA/Generic Communications Plan Restoring Best Of Past Practices

 
• By Derrick Gingery

Office of Generic Drugs wants to allow project managers to inform sponsors of major deficiencies before ‘complete response’ letter as part of ‘go/no go’ effort.

Generic sponsors may find some familiar practices in upcoming updates to the Office of Generic Drugs’ communications policy.

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Dramatic HHS Layoffs A Response To ‘Existential Crisis,’ Kennedy Advisor Argues

 
• By Cathy Kelly

Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.

Makary Pledges To Uphold Gold Standard Science, But First Address Confuses Some US FDA Staff

 
• By Derrick Gingery, Sarah Karlin-Smith, and Sue Sutter

Some employees were not impressed with FDA Commissioner Martin Makary's first speech to the agency staff, saying he did not seem to understand the agency's mission.

Are Bigger Ad Policy Changes Coming After US FDA’s Drug Promotion Office Hit Hard By Layoffs?

 
• By Sue Sutter

The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.