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House Passes US OTC Monograph Reform And Committee Clears HSA Change

 
• By Malcolm Spicer

Next step for OTC monograph reform legislation is Senate consideration; market exclusivity periods are likely focus of House/Senate conference. Separate bill to allow consumers to use health savings accounts to buy OTC drugs without a doctor's prescription clears House Ways and Means panel.

Washington DC Capitol dome detail with waving american flag

The US House of Representatives has been busy on consumer health products policy, making progress on one proposal to streamline how FDA evaluates OTC monograph proposals and another on how consumers can pay for nonprescription drugs.

On July 16, the full chamber passed the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018, H.R. 5333. It would allow FDA to use administrative orders, rather than conduct...

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• By Eliza Slawther

The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.

Pharma DTC Ad Tax Break Targeted By US HHS, Congress

 
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Health and Human Services Secretary Robert F. Kennedy Jr. said a policy that would remove the tax write-off for pharma advertising expenses would be coming in a few weeks.

BIOSECURE Act Returning, Privacy, Gain-of-Function Bills Coming, Senate Sponsor Says

 
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• By Jung Won Shin

As South Korea gears up for a snap presidential election, its biopharma industry proposes key desired policies to candidates, most of whom have not laid out detailed plans of their own for the sector.

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EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

UK And US Regulators In Sync On RWD External Control Arms

 
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New EU Approvals

 
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