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Drug Shortage Provisions In Draft PDUFA Bill Would Expedite Major Manufacturing Changes

 
• By Cathy Dombrowski

FDA would have 60 days to review major changes and could “deem” them compliant with current good manufacturing practices so long as the facility has a plan and resources to achieve full compliance and institutes quality control measures under draft legislation being developed by the House Energy and Commerce Committee.

FDA could approve major manufacturing changes that may prevent or alleviate drug shortages even if those changes are not immediately compliant with current good manufacturing practices, under legislation being drafted by the House Energy and Commerce Committee to reauthorize the prescription drug and other user fee programs.

The draft bill, which is intended for discussion purposes, has a number of add-ons to the fees, including...

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• By Neena Brizmohun

The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
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If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

US FDA’s Familiar Drug Pricing To-Do List

 
• By Michael McCaughan

President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

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EU Emergency Response Authority Needs Bigger Budget To Address Health Threats, Says Industry

 
• By Eliza Slawther

The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

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PBM Investigation, Enforcement Action ‘Critical Priorities’ At FTC, Chair Says

 
• By Cathy Kelly

The new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.