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GPhA and its European counterpart want the FDA and European Medicines Agency to create uniform approval pathways for biosimilars and generics, saying standardization would lower drug costs and eliminate the need for duplicate clinical trials for the same product. Read More
Indian authorities quietly suspended Ranbaxy’s Toansa facility from exporting active pharmaceutical ingredients to Europe late last month, signaling the country’s new, tougher approach to manufacturing quality violations. Read More
GPhA and its European counterpart want the FDA and European Medicines Agency to create uniform approval pathways for biosimilars and generics, saying standardization would lower drug costs and eliminate the need for duplicate clinical trials for the same product. Read More
The FDA has banned imports from active pharmaceutical ingredient maker Canton Laboratories, the fourth Indian drugmaker in a month to be put on import alert for poor quality. Read More
Boehringer Ingelheim and Eli Lilly said Monday that the FDA has accepted their NDA for a first-in-kind drug combination to treat type 2 diabetes. Read More
The FDA has banned imports from active pharmaceutical ingredient maker Canton Laboratories, the fourth Indian drugmaker in a month to be put on import alert for poor quality. Read More
GPhA and its European counterpart want the FDA and European Medicines Agency to create uniform approval pathways for biosimilars and generics, saying standardization would lower drug costs and eliminate the need for duplicate clinical trials for the same product. Read More
Impax said Friday it has refiled an NDA for its Parkinson’s disease drug Rytary after implementing quality systems improvements at the plant where the drug was slated to be made. Read More
Indian authorities quietly suspended Ranbaxy’s Toansa facility from exporting active pharmaceutical ingredients to Europe late last month, signaling the country’s new, tougher approach to manufacturing quality violations. Read More
The European Medicines Agency is looking into potential heart risks linked to testosterone-containing drugs after an EU member state regulator raised safety concerns. Read More