OR WAIT null SECS
December 02, 2018
EMA’s relocation to Amsterdam and resulting staff losses could severely weaken the agency’s role as a leading medicines regulator.
GMP non-compliance can spill over and impact patient access to life-saving medications.
FDA Commissioner Scott Gottlieb has been promoting drug market competition in recent months that includes new guidance documents and targeted advisories to support R&D of complex drugs and combination products.
November 29, 2018
Despite ongoing efforts to address the problem, FDA now sees a rise in active shortages and in the duration of supply problems.
November 27, 2018
The agency has approved two new chemical entities, Daurismo (glasdegib) from Pfizer, and Vitrakvi (larotrectinib) from Loxo Oncology, for treating cancers.
November 16, 2018
The positive opinions included the first oral-only tablet for the treatment of human African trypanosomiasis.
After a review of serious side effects, the agency decided to suspend marketing authorizations for quinolone and fluoroquinolone antibiotics and restrict use of remaining fluoroquinolone antibiotics.
November 15, 2018
The agency provided an update on its relocation plans and assured that core activities are continuing uninterrupted.
The new good pharmacovigilance practice chapter IV on specific considerations for the pediatric population offers a holistic view of pediatric pharmacovigilance and provides guidance on how to address the specific needs and challenges of safety monitoring of medicines used in children.
November 14, 2018
The agency sent a warning letter to the company for marketing an unapproved stem cell product and CGMP violations.