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Drug Safety

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Latest From Drug Safety

FDA Busy Sorting OTC Monograph Ingredients Anticipating System Overhaul

FDA has yet to finalize about one-third of its OTC monographs and several hundred ingredients do not have a final GRASE determination. Sorting will help the agency determine which of the 800 active OTC monograph ingredients are designated as needing more information to establish GRASE under a faster system based on administrative orders.

Consumer Drug Approval Standards

EU, US Regulators Examine Birth Defect Concerns For 'One Of The Safest' HIV Drugs

Four cases of birth defects associated with HIV drug dolutegravir have prompted the EU and US regulators to recommend discontinuing its use in women seeking to get pregnant until the issue is investigated further. The development comes as a surprise because dolutegravir is regarded as one of the safest and most potent drugs for HIV treatment.
Drug Safety Europe

Liver Damage Worries Lead To Further EU Restrictions On Richter’s Esmya

The European Medicines Agency’s pharmacovigilance committee has recommended more restrictions on the use of Richter’s Esmya because of concerns over the risk of serious liver damage.
Drug Safety Europe

EMA Panel Finalises Safety Probe Into Richter’s Fibroid Drug Esmya

Gedeon Richter’s uterine fibroid drug, Esmya (ulipristal acetate), is expected to be the subject of a safety recommendation by the EMA’s pharmacovigilance committee this week.

Drug Safety Europe

Smaller OTC Loperamide Packages Wait As Retailers Limit Purchase Amounts

Commissioner Scott Gottlieb updates US FDA's initiative to prevent potentially fatal abuse of OTC loperamide, noting that online and conventional retailers are limiting product purchases while the agency continues evaluating the appropriate number of doses per package.

Consumer Drug Safety

US FDA Rethinking Post-Market Safety Function As Part Of New Drug Review 'Modernization'

CDER Deputy Director Cavazzoni is leading the review, further indicating her status as heir-apparent to long-time drug center director Janet Woodcock. 
Drug Review Drug Safety

Industry/EMA Discuss Early Concerns Over EU’s Safety Signal Reporting Pilot

Industry representatives have raised some issues around the EU’s pilot program for drug safety signal monitoring and reporting via the revamped EudraVigilance system.

Drug Safety Europe

At Stannsoporfin Advisory Committee, Talk Of Additional Studies Stirs Feasibility Doubts And High Emotions

InfaCare’s jaundice drug needs more neurodevelopmental outcome studies, US FDA committee says, but one panelist doubts feasibility of long-term follow-up; talk of additional studies leads to an unusual tongue-lashing from one of InfaCare's experts, who says he was 'stunned' by the committee’s conclusion that efficacy had not been shown.

Advisory Committees Drug Approval Standards

New ICH Q&A To Support Uptake Of 'Vague' Safety Guideline For Anticancer Drugs

All parties that have used the ICH S9 guideline on the non-clinical evaluation of anticancer medicines have experienced challenges around its implementation, highlighting the need for additional clarity. A new Q&A document is expected to support its uniform implementation.
Drug Safety Regulation
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