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Latest From Drug Safety

WHO Wants More Transparency From Industry On Falsified Medicines Scourge

The World Health Organization estimates that one in 10 Medicines in the developing world are falsified. It says that the pharmaceutical industry needs to be more transparent about the problem.

Drug Safety Healthcare Systems

Australian Online Tool To Take Tedium Out Of Identifying New PI

The TGA says that its new search function to help generic drug sponsors identify new and updated product information will become more valuable over time.

Post Market Regulation & Studies Drug Safety

US FDA Monitoring Online Forums For Research Into Opioid Misuse And Abuse

The goal of monitoring Twitter and chat rooms is to proactively identify patterns of misuse and abuse before they fully manifest, Commissioner Gottlieb says.

Drug Safety FDA

Breakthrough, Fast-Track Pathways Match Their Hype Of Reduced Development Times - JAMA

Although study was meant to be critical of expedited pathways, it showed that drugs with at least one of the designations experience lower clinical development times.

Review Pathway Drug Approval Standards

Does FDA Rejection Of Label Warning Shield Manufacturers From Tort Suits?

US Supreme Court asks Solicitor General to weigh in on Merck petition requesting clarification of its Wyeth v. Levine ruling; Third Circuit says decision is 'cryptic and open-ended.'

BioPharmaceutical Legal Issues

Keytruda: US FDA Reflects On Lessons Learned From Failed Myeloma Studies

Importance of randomized, controlled trials and need for a thoughtful, considered approach to development of rational combinations are highlighted by the increased mortality risk seen with pembrolizumab treatment in two halted multiple myeloma studies, FDA officials say.

ImmunoOncology Clinical Trials

EMA Stands By Recommendation To Suspend Modified-Release Paracetamol From Market

The EMA’s drug safety committee has re-examined its recommendation in September to suspend modified-release paracetamol at the request of two companies that sell such products.

Drug Safety Post Market Regulation & Studies

The End Of ‘Regulatory Science’ At US FDA – The Term, Not The Idea

Former Commissioner Margaret Hamburg made advancing regulatory science a centerpiece of her tenure, but it sounds like the term ‘regulatory science’ has outlived its usefulness.

Regulation FDA

Labeling Updates For Old Drugs Could Be Faster Under Streamlining Proposal

Stakeholder group's proposed pilot program to correct outdated drug labeling calls for US FDA to identify older products needing updates and contract out for evidence reviews, but agency and generic drug industry raise concerns about complexity, resources and product liability.

Drug Approval Standards Generic Drugs
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