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The FDA has acquiesced to industry concerns and promised not to take action against drug supply chain companies for failing to exchange product information before May 1. Read More
The FDA in 2015 plans to begin work on a nationwide network of electronic health records and insurance claims data it will use to investigate drug safety questions that emerge from adverse event reports or other sources. Read More
The FDA last week issued its 12th warning letter in 2014 for data integrity violations, out of 18 total warning letters released over good manufacturing practices, with foreign facilities drawing most of the criticisms. Read More
The FDA approved seven new drugs last month, pushing its total to 41 last year, the highest number of new molecular entities cleared by the agency since 1996. Read More
The FDA in 2015 plans to begin work on a nationwide network of electronic health records and insurance claims data it will use to investigate drug safety questions that emerge from adverse event reports or other sources. Read More
The FDA last month warned a Chinese active pharmaceutical ingredient (API) maker for data integrity violations, marking the agency’s 13th warning letter to cite data integrity out of 18 overall warnings released in 2014 for quality violations. Read More
Actavis must keep its Alzheimer’s drug Namenda on the market for now, but a recent agreement with the New York Attorney General will let the company avoid notifying more than half a million people of that fact. Read More
Vertex Pharmaceuticals’ cystic fibrosis drug Kalydeco has won FDA approval for an additional indication to treat patients six years and older with at least one copy of the R117H gene mutation. Read More
The FDA approved Hospira’s nonsteroidal anti-inflammatory drug (NSAID) analgesic Dyloject to treat mild to moderate pain as well as moderate to severe pain either on its own or in combination with opioid analgesics. Read More