Drug Pricing Panacea Or Just PR Victory? Expedited ANDAs May Have Limited Impact

In theory, reviewing generic applications faster should speed competition; in practice, FDA's new policy likely won't make too much difference.

FDA has slightly expanded the types of ANDAs eligible for expedited review, but the change may not provide much of an incentive for generic firms to pursue a particular market.

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‘Highly Problematic’: Acting FDA Commissioner Paused Planned OK Of Novavax Shot

 

Former Acting FDA Commissioner Sara Brenner is said to have asked Tracy Beth Høeg, new special assistant to the commissioner, to help reexamine the application. Høeg’s position at the agency is raising concerns about the FDA's ongoing approach to vaccine regulation.

Trump Tariffs: Indian Pharma Dodges Bullet, But Sword May Remain

 
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Trump announced a 26% reciprocal tariff on India, but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?

Dr. Oz Takes The Over CMS Amid Major Transformation Of Medicare Part D

 
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As CMS administrator, Mehmet Oz will oversee the second year of Medicare drug price negotiations and Part D redesign issues, but will have experienced deputies to help.

US FDA Restructuring May Be Next After Drugs Center Loses More Than 1,000 People

 

The departure data emerged along with a Health and Human Services Department memo describing conceptual plans to consolidate and restructure offices at the FDA and other agencies.

More from North America

Pharma Exhales, Dodges Financial Blow With Tariff Exemption

 

Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.

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

 
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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

 

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.