Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Drug Safety

Set Alert for Drug Safety

Latest From Drug Safety

Why The US FDA Requested Ranitidine Withdrawal; How Other Withdrawals Could Follow

Agency worried what might happen beyond expiry or room temperature to generate carcinogenic impurities in ranitidine; will guide assessment of nitrosamine risks in other drugs.

Compliance Manufacturing

US FDA Eases Up On Adverse Event Reporting During COVID-19

Issued as part of the new approach to releasing guidances during the pandemic, FDA said flexibility was needed for two reasons: anticipated higher levels of absenteeism among staff for both sponsors and the agency, and the necessity of prioritizing a focus on adverse events for products used to treat coronavirus.

Safety Coronavirus COVID-19

EMA Updates Board On Business Continuity And Coronavirus

The European Medicines Agency’s first management board meeting of 2020 was held virtually and was shortened but covered a number of topics including COVID-19.

Europe Regulation

Palforzia Peanut Allergy Immunotherapy: Aimmune CEO On REMS Restrictions, Manufacturing

Aimmune CEO Jayson Dallas tells the Pink Sheet how physicians and patients are being certified to use Palforzia and how the product's food-based manufacturing process is actually an advantage. 

Safety Manufacturing

Ulipristal Suspended In EU Pending Further Review

Gedeon Richter's Esmya should not be prescribed to women while the European Medicines Agency again reviews the risk of serious hepatic injury. 

Europe Drug Safety

Pink Sheet Podcast: US FDA Announces Coronavirus Containment Strategy, Issues Updated Type 2 Diabetes Guidance

Pink Sheet reporter and editor consider the fall-out from the FDA decision to cancel meetings and postpone inspections due to the coronavirus pandemic, as well as look at the new cardiovascular recommendations for Type 2 diabetes drug development.

Coronavirus COVID-19 Clinical Trials

Type 2 Diabetes Drugs Can Skip Cardiovascular Outcome Trials, But Phase III Must Be Longer, Broader

US FDA withdraws controversial 2008 guidance that required sponsors to exclude threshold levels of cardiovascular risk before and after approval; new draft guidelines emphasize duration of exposure and breadth of safety evaluations in more diverse Phase III trial population, consistent with advisory committee recommendations.

Drug Safety Clinical Trials

US FDA Orders Singulair Boxed Warning On Neuropsychiatric Events Despite ‘Limited’ Evidence

Therapeutic alternatives and lack of prescriber and parent knowledge about existing warnings drove agency’s decision, despite internal concerns about the adequacy of the evidence to support the safety action.

Drug Safety Post Market Regulation & Studies

Philippines FDA Tackles Confusion Over Pharmacovigilance Requirements

The country's Food and Drug Administration says its previous guidelines on pharmacovigilance were unclear on a number of fronts.

Philippines Drug Safety
See All
UsernamePublicRestriction

Register