Category Archives: Safety
By William Looney | Published: July 1, 2014
Is the FDA doing enough to incorporate the patient perspective in the drug review process? This was the key question considered at a panel of regulatory experts held at last month’s annual BIO International Convention in San Diego. The consensus: while FDA deserves high marks for effort, both in reconciling the diversity of patient organization […]
By Reflector | Published: June 20, 2014
While action is heating up at the international level to tackle counterfeit drugs, Europe is making its own efforts to stop fake medicines from entering the legal supply chain. An improbable cross-sector partnership is struggling to secure support for a pan-European system to keep counterfeits out. It’s improbable because it brings together not only manufacturers, […]
By Pharm Exec | Published: June 13, 2014
The European Medicine Agency’s Pharmacovigilance and Risk Assessment Committee (PRAC) has started a review to evaluate the cardiovascular risks with systemic ibuprofen medicines.
By Pharm Exec | Published: June 3, 2014
Eli Lilly and Company has announced it will begin sharing its clinical trial data with scientific researchers through www.clinicalstudydatarequest.com. The website, which houses data from several clinical trial sponsors, was created with support from PhRMA and EFPIA to increase access to and transparency of clinical trial results for researchers around the world.
By Jill Wechsler | Published: May 13, 2014
In anticipation of the 200th anniversary of the United States Pharmacopeia (USP) in 2020, the organization’s new leadership is taking a fresh look at its role in setting standards for pharmaceutical development and production and how that has been altered by new regulatory policies and industry globalization. USP chief executive officer Ron Piervincenzi is consulting […]