Union of Concerned Scientists' survey finds 65% of 354 respondents feel their direct supervisors back them on politically contentious positions; Commissioner Gottlieb gets glowing reviews.

Consumer Healthcare Products Association looks to stem expansion of state-mandated drug take-back programs with programs that use existing facilities and infrastucture and don't require industry funidng, says state affairs VP Carlos Gutierrez. State bills limiting sales of DXM to minors and expansion of the NPLEx system to track PSE sales also are on CHPA’s radar.

The BioIndustry Association says life sciences could be among the first sectors to be addressed in the UK government’s planned release of “technical notices” regarding the effects of a “no-deal” Brexit.

A political crisis between Turkey and the US has seen the Turkish lira plunge in value against the euro and other major currencies and is having a negative impact on the availability of drugs in Turkey.

HHS meeting with stakeholders may lead to adjustments to plan for implementing step therapy in Medicare Advantage for Part B drugs.

Proposed list of topics for review in 2019 by the Institute for Clinical and Economic Review includes a total of 15 drugs but that could change as the year goes on.

The European Medicines Agency is revising its guidance on clinical trials of drugs for treating epileptic disorders.

US FDA encouraging developers to embrace cross-labeling rather than continue separate development of proprietary PD-1 agents, but agency sounds eager for any other good ideas to pare back the number of checkpoint inhibitors in development. 

Vertex says it will not file data on its cystic fibrosis drug Symkevi (tezacaftor/ivacaftor) until the UK's NICE changes the way it assesses drugs.

Submitting an OTC switch of Nasonex would be a first for Perrigo, as would marketing a national brand OTC if the switch is approved. In tandem with announcing divesture of Perrigo's Rx business, CEO Uwe Rohrhoff says marketing national brands in some OTC categories fits in the company's "value-creation road map."

ICH relaxing a new limit for inhaled cadmium in drugs; FDA relaxes timeline for quality metrics site visit invitations; US FDA looks for heparin test to sort the porcine from the bovine and ovine; and universities win FDA grants for research into continuous pharmaceutical manufacturing.

FDA’s final guidance on chewable tablets clarifies what is meant by a “chewing difficulty index” to assess product hardness. Properly formulating these products is key to avoiding quality failures such as choking patients.

Apotex warning letter reflects FDA’s emphasis on company-wide quality systems and invalidated OOS results.

FDA’s final guidance on chewable tablets clarifies what is meant by a “chewing difficulty index” to assess product hardness. Properly formulating these products is key to avoiding quality failures such as choking patients.

Consumer Healthcare Products Association looks to stem expansion of state-mandated drug take-back programs with programs that use existing facilities and infrastucture and don't require industry funidng, says state affairs VP Carlos Gutierrez. State bills limiting sales of DXM to minors and expansion of the NPLEx system to track PSE sales also are on CHPA’s radar.

While FDA does not identify specific product types on the agenda for its public workshop on approaches in skin toxicity testing for topical drug products, advocacy and trade groups anticipate sunscreen ingredient testing could be among the discussion topics. Product expansions have been stifled by regulatory concerns, drawing particular attention from the public health community.