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Suggested US Smoking Cessation Roadmap Destinations: Fast Track, Incentives, Indications

 
• By Malcolm Spicer

Potential changes in FDA’s consideration of NRT proposals stated in recent New England Journal of Medicine article by smoking cessation advocates. Cigarettes, “deadliest form of nicotine delivery,” are “subject to limited oversight,” but "products marketed to help people quit smoking face far more substantial regulatory barriers,” they write.

• Source: Shutterstock

Progress toward expanding smoking cessation options in the US and increasing the number of smokers who quit could come from changes in regulatory processes so innovations in nicotine replacement therapies have a better chance for success, advocates suggest.

A roadmap for potential changes in the Food and Drug Administration’s consideration of NRT proposals was provided in a recent...

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While FDA fully supports the recent roadmap to reduce and eliminate animal testing, animal tests are still necessary for assessing systemic effects, says Jacqueline Corrigan-Curay, acting director for CDER, during a House Energy and Commerce Health Subcommittee hearing.

Pharma Deutschland Seeks To Enter Urban Wastewater Legal Dispute

 
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The Urban Wastewater Treatment Directive “in its current form, is at an end,” insists Pharma Deutschland CEO Jörg Wieczorek. To put the directive to bed once and for all, the association has applied for leave to intervene in the ongoing EU legal battle in its own right.

Cloudy Tariff Conditions Expected To Linger In US

 
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More from Policy & Regulation

US FDA: No Replacement Yet For Animal Methods In Testing Systemic Effects Of Sunscreens

 
• By Lauren Nardella

While FDA fully supports the recent roadmap to reduce and eliminate animal testing, animal tests are still necessary for assessing systemic effects, says Jacqueline Corrigan-Curay, acting director for CDER, during a House Energy and Commerce Health Subcommittee hearing.

House Health Subcommittee Members Agree OMUFA Crucial, Split On FDA Staff Cuts’ Impact

 
• By Malcolm Spicer

Subcommittee members aren’t on same page about whether FDA staff cuts ordered by the Trump administration will prevent the agency from fulfilling its responsibilities for the OTC drug sector.

House OMUFA Reauthorization Bill Takes On Clarifying Standards For Tests To Meet GRASE

 
• By Malcolm Spicer

Health Subcommittee will discuss reauthorizing OMUFA during a hearing on how to “maintain and improve” the public health workforce and rural health as well as access to OTC medicines.