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Drug Safety

Set Alert for Drug Safety & Safety

AI and Adverse Events: Tech Not Ready For Prime Time For Case Safety Reports, US FDA Says

FDA leadership weighs in on limitations of AI as part of rollout of new technology meeting program that looks to give industry and other stakeholders a chance to inform future regulation.

Artificial Intelligence Drug Safety

Australia Proposes Clearer Labeling For Injectables To Ensure Safety & Efficacy

A targeted review of the rules on labeling for injectable medicines is being carried out in advance of a wider updating of labeling requirements that took effect in 2020.

Asia Pacific Australia

SCOTUS' Mifepristone Decision Sets High Bar For US FDA Suits, But Risks To Agency Authority Linger

The unanimous decision that the Alliance for Hippocratic Medicine lacks standing to challenge the FDA’s relaxation of the abortion pill REMS leaves unclear whether the court would have deferred to the agency’s expertise on the merits.

Drug Safety Legal Issues

ICH Cuts Burden Of Assessing Drug-Drug Interactions; Argentina Gains Membership

New guidance from the International Council for Harmonisation is designed to tackle problems companies face by having to meet different requirements around the world when evaluating the potential of DDIs for their investigational products.

International Drug Safety

Pharmacogenomics Could Reduce Annual £2bn Cost Of Adverse Drug Reactions In UK

With more than 16% of hospital admissions in the UK caused by adverse drug reactions, costing the country upwards of £2bn a year, a genomics expert explains how pharmacogenomic tests could benefit both patients and the health care system.

BioPharmaceutical Drug Safety

Regulators Tackle Challenges With Pharmacoepidemiological Studies That Use RWD

An internationally harmonized framework for generating adequate evidence using fit-for-purpose real-world data to address regulatory questions on the safety of medicines is out for public consultation.

Post Market Regulation & Studies Europe

Lykos’ MDMA Heads To AdComm With US FDA Concerns About Adverse Event Reporting

‘Short-term effects of midomafetamine were not captured’ in the clinical program for post-traumatic stress disorder, FDA notes. Proposed REMS for the psychedelic therapy to be discussed at 4 June would limit dispensing setting, restrict post-treatment driving.

Advisory Committees Drug Safety

Joint Clinical Assessments Of ATMPs Add To Ethical Concerns Over Need For Randomized Trials

Advances in cell and gene therapy, together with the forthcoming EU joint clinical assessments, have raised questions about the ethics of having to use randomized controlled trials to test new advanced therapies.

Europe Drug Approval Standards

EU To Suspend 17-OHPC Preterm Birth Drugs A Year After US Pulled Makena

17-OHPC medicines are to be pulled from the market in Europe due to a potential link with cancer and the lack of efficacy data. The move comes around a year after the US regulator withdrew its approval of a similar drug from Covis.

Post Market Regulation & Studies Europe

End In Sight For Onerous EU Signal Detection Pilot

A keenly-awaited legislative amendment that is expected to be adopted by the end of this year would introduce more proportionate requirements for drug sponsors to monitor the EudraVigilance database.

Europe Drug Safety

US FDA Inspectors, Product Centers Working Closer Together Ahead Of ORA Reorg

Compliance functions will be moved to the product centers when ORA becomes the Office of Inspections and Investigations, and centers will become responsible for making the final agency decision on inspection classifications, Associate Commissioner Michael Rogers said.

Enforcement Quality

EU Urban Wastewater Directive Update ‘Unfairly Targets Pharmaceutical Industry’

The European Parliament has voted for a deal agreed with the council of ministers to ensure polluters pay for cleaning up urban wastewater.

Europe Germany

It’s Official: FDA Drops Final Rule On LDTs

The US FDA's controversial final rule places laboratory developed tests under same regulatory purview as other in vitro diagnostics. While the agency opted to include an exemption for LDTs already on the market, it did not provide an exemption for tests developed in academic medical centers.

In Vitro Diagnostics Legal Issues

EU And South Korea Sign Deal On Exchange Of Confidential Information

The EU and Korean authorities say the agreement will allow them to further develop moves towards mutual recognition and regulatory harmonization.

Europe South Korea

Puberty Blockers: FDA's Califf Asked If REMS, Boxed Warning Against Off-Label Use In The Works

FDA Commissioner Robert Califf tells House appropriations subcommittee chair the agency will 'consider any information that may be available' on off-label use of puberty blockers for gender dysphoria before making a regulatory decision.

Hormonal Drug Safety

Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa

The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.

US FDA Performance Tracker Approvals
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