Regulatory

Aug 14, 2015
BioPharm International
By BioPharm International Editors
The company is in discussions with Europe’s Adaptive Pathways Group on clinical trials that would evaluate its PLX cells for the treatment of specific diseases.
Aug 12, 2015
FDA determined the celebrity’s endorsement of Duchesnay’s morning-sickness medication Diclegis was misleading.
Aug 01, 2015
BioPharm International
This article discusses cleaning validation of equipment dedicated to the production of a single API.
Jul 17, 2015
The bill would authorize spending of approximately $8.1 billion on transit projects through 2015 while legislators plan a long-term bill that could have implications for the pharmaceutical industry.
Jul 14, 2015
By BioPharm International Editors
The agency requires early notification of potential drug shortages.
Jul 14, 2015
By BioPharm International Editors
FDA released news of the ban of Emcure’s Hinjewadi manufacturing plant after it determined the plant did not meet basic quality standards.
Jul 07, 2015
The amendment suggests modifications to the calculation of a drug's average manufacturing price and to the reimbursement rate for infused medications.
Jul 01, 2015
BioPharm International Multimedia
By BioPharm International Editors
Sue Schniepp, Chair, PDA Regulatory and Quality Advisory Board, and Hal Basemen, Chair, PDA, spoke with BioPharm International about resolving drug shortages.
Jul 01, 2015
BioPharm International Multimedia
By BioPharm International Editors
Sue Schniepp, Chair, PDA Regulatory and Quality Advisory Board, and Hal Basemen, Chair, PDA, speak with BioPharm International.
Jul 01, 2015
BioPharm International
The European Union has a challenging task ahead as it strives to harmonize regulations on advanced therapy medicinal products.
native1_300x100
lorem ipsum