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Latest From Drug Safety
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.
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.
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.
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.
Gedeon Richter's Esmya should not be prescribed to women while the European Medicines Agency again reviews the risk of serious hepatic injury.
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.
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.
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.
The country's Food and Drug Administration says its previous guidelines on pharmacovigilance were unclear on a number of fronts.
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