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Will Opioid Supply Be Slashed? US Attorney General Takes Aim At Aggregate Production Quotas

 
• By Brenda Sandburg

Looking to reduce opioid prescriptions, Sessions asks DEA to consider revising regulations governing its quotas. President Trump says DOJ may file separate suit against opioid makers.

Hydrocodone prescription bottle. Hydrocodone is a generic medication name and label was created by photographer.

US Attorney General Jeff Sessions is encouraging the Drug Enforcement Administration to change the way it sets annual opioid aggregate production quotas as a way to reduce the number of opioid prescriptions.

Sessions sent the Acting Administrator of the DEA a memo on March 1 directing the agency to "consider whether...

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EU Fines Alchem Over Buscopan API Cartel

 
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Clinical Trial Diversity Action Plan Guidance Must Return To US FDA Website, Court Says

 
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HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

Lawyers Weigh In On ‘Sunshine’ Clause In EU Pharma Reform Package

 
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The Council of the EU has not taken forward a proposal from the European Parliament that would require companies to disclose the transfers of value they make to health care professionals and health care organizations – lawyers weigh in on the diverging proposals.

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EMA’s PRIME Scheme Explored: Growing Designations - But Are Accelerated Assessments Slipping?

 
• By Neena Brizmohun

While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.

Global Pharma Guidance Tracker - June 2025

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.