News dal mondo
06
Feb
US FDA to publish additional guidance to ‘genericize’ complex drugs
As complex drugs see little competition, the FDA will distribute guidelines to increase approvals of generic medicines for ‘economic stability’ and to bring affordable drugs to patients... [in-PharmaTechnologist]
22
Swissmedic Started to Enter GMP Compliance Information into EudraGMDP
The Swiss Agency for Therapeutic Products (Swissmedic) has started in 2019 to enter information on Good manufacturing practice (GMP) compliance...
21
EU Takes Another Step Towards Adopting SPC Waiver Proposal
The European Union's proposal to allow manufacturing waivers to supplementary protection certificates (SPC) is one step closer to adoption after...
20
European manufacturing waiver to ‘level the playing field’
Pharmaceuticals: Commisssion welcomes agreement on proposal to facilitate EU exports The Commission welcomes the political agreement...
14
US FDA CDER Proposes Program to Create Voluntary Pharmaceutical Quality Standards
With an aim to promote innovation in pharmaceutical development and manufacturing, the US Food and Drug Administration's (FDA) Center for Drug...
