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Latest From Drug Safety

Unlicensed Stem Cell Clinics Are 'Surrogate' For Right To Try, US FDA's Marks Says

CBER director said unlicensed stem cell clinics often report adverse events not made public, which is a concern under Right To Try.
Drug Safety Clinical Trials

US FDA Launches Study Of Prescriber Perceptions About Abuse-Deterrent Opioids

The agency is assessing whether to use different language to describe addiction and abuse deterrence.
Drug Safety Neurology

Opioid Prescribing Guidelines Will Be More Template Than Commandment

Commissioner Gottlieb says US FDA does not intend to force physicians to adhere to opioid prescribing guidelines being developed by National Academies of Sciences, Engineering, and Medicine.
Drug Safety Neurology

The Meta-Physics Of Meta-Analysis: US FDA’s Curious Framing Of New Safety Guidance

Long delayed guidance on meta-analysis “will assist sponsors of drug and biological products in designing safety meta-analyses of randomized controlled trials using best practices,” FDA Commissioner says. True – but is that really the point? 
Clinical Trials Drug Safety

Mexico and Argentina To Cut Burden for Pharma By Swapping GMP Reports

Medicines regulators in Mexico and Argentina have agreed to exchange good manufacturing practices inspection certificates.

South America Argentina

Gottlieb Renews Call For New Opioid Review Paradigm As Democrats Prepare For House Control

US FDA's controversial approval of Dsuvia may prompt incoming House Democrats to pay special attention to commissioner's remarks on how agency reviews opioids. 
Neurology Elections

Drug Safety Meta-Analyses: US FDA Emphasizes Trial Quality Over Quantity

Three years overdue, agency draft guidance seeks to inject a threshold level of rigor into meta-analyses of randomized, controlled trials to evaluate drug safety and proposes a three-tiered hierarchy of evidence against which FDA will evaluate such studies for regulatory decision-making purposes.

Drug Safety Post Market Regulation & Studies

US FDA's Internal Debate On Sage's Brexanolone Spills Into Open During Panel Review

Bob Temple and Ellis Unger discuss feasibility of studies for postpartum depression drug as advisory committee members wait to discuss the dosing questions they had been convened to consider.
Advisory Committees Neurology

Tearing Down The Goalposts (Part 3): “Was It Worth It”?

When US FDA adopted new outcomes standards for novel diabetes drugs in 2008, there were dire warnings that it would kill product development for the disease. When an advisory committee revisited the issue in 2018, however, there was almost unanimous agreement that the guidelines have been positive. Almost. 
Drug Safety Advisory Committees
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