Archives for January 22, 2018

Q&A

FDA ‘taking an important step’ with new clinical trial transparency pilot program

The US Food and Drug Administration (FDA) is launching a new pilot program this month aimed at increasing clinical trial transparency – though many opportunities remain to improve the scope, clarity, and usability of data, says TrialScope CSO.

CRO Biorasi on East-Asian expansion: Why Japan, and where to next?

Japan’s proximity to China, pharmaceutical infrastructure, and workforce capabilities helped inform Biorasi’s decision to launch regional headquarters in Tokyo, says executive.

Common Rule delayed 6 months or more following lack of guidance, other challenges

Revisions to the Federal Policy for the Protection of Human Subjects has been delayed six months, possibly more, as regulators cite the rule’s complexity, lack of guidance, and other challenges.

US FDA has stopped taking fees and accepting drugs for review as a result of shutdown

The US FDA has stopped accepting drugs for review and said it will not conduct any plant inspections during the US Government shutdown.

Pfizer blames Canadian EpiPen shortage on manufacturing complexities

Pfizer says ongoing remediation to the quality validation process at its supplier has resulted in a shortage of EpiPen auto-injectors in the 0.3 mg format.

Environmental tax will impact firms that use China-made drug intermediates say experts

China’s environmental tax will mean higher costs for drug and API firms that rely on intermediates made in the country say industry experts.