Regulatory Authority Actions

Nov 16, 2018
By Pharmaceutical Technology Editors
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.
Nov 16, 2018
By Pharmaceutical Technology Editors
The positive opinions included the first oral-only tablet for the treatment of human African trypanosomiasis.
Nov 15, 2018
By Pharmaceutical Technology Editors
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.
Nov 15, 2018
By Pharmaceutical Technology Editors
The agency provided an update on its relocation plans and assured that core activities are continuing uninterrupted.
Nov 14, 2018
By Pharmaceutical Technology Editors
The agency sent a warning letter to the company for marketing an unapproved stem cell product and CGMP violations.
Nov 12, 2018
Pharmaceutical Technology
Pharma companies are concerned they may have to postpone plans for the commercialization of new combination products because of delays in obtaining marketing authorizations because of a lack of clarity about approval rules.
Nov 12, 2018
By Pharmaceutical Technology Editors
The agency is developing a new way to assess, record, and report data from surveillance and preapproval inspections of sterile drugs.
Nov 09, 2018
By Pharmaceutical Technology Editors
Investigatory work arranged by Swissmedic has revealed that sartan-containing medicines on the Swiss market are safe in respect of NDMA.
Nov 08, 2018
By Pharmaceutical Technology Editors
The decision follows an FDA request for additional information to complement the company’s submission for biosimilar rituximab.
Nov 08, 2018
Leaders of the two parties are open to challenging the status quo on drug costs and spending.
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