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The European Medicines Agency has recommended that three medicines manufactured by Pharmaceuticals International Inc. (PII) no longer be available in the EU due to possible cross-contamination. Read More
Lima & Pergher Industria failed to provide stability data to ensure its drug products’ expiration dates and did not perform microbiological testing on each finished product, the FDA said in a warning letter to the Brazilian company. Read More
Despite significant potential savings in time and money, drug and medical device manufacturers have been slow to embrace continuous manufacturing, an FDA technology official said. Read More
A year from now, each drug product processed and moved through the U.S. supply chain could have its own unique identifier under the Drug Supply Security Act, FDA and industry officials said at a meeting Monday. Read More
Pfizer is pressing the FDA to extend the market exclusivity of its combination drug Duavee, following a judge’s ruling that the FDA had inconsistently interpreted the eligibility criteria. Read More
The FDA encouraged additional development in topical treatments for head lice infestation, especially in pediatric populations, due to the genetic resistance to the most common treatments. Read More
The DEA has reduced the amount of Schedule II opiate and opioid medications that can be manufactured in the U.S. next year by at least 25 percent. Read More
NICE is endorsing AstraZeneca’s Forxiga as a treatment for Type 2 diabetes in combination with metformin and a sulfonylurea, marking the agency’s third favorable recommendation for the drug. Read More
A European Parliament committee is proposing that the European Commission promote transparency in private research to foster better access to medicines across the EU. Read More
For years, Mylan has dodged paying the appropriate rebates for its epinephrine auto-injector EpiPen through a misclassification, the Centers for Medicare and Medicaid Services confirmed. Read More
The FDA intends to clarify its expectations for demonstrating the interchangeability of biosimilars with reference products, an FDA official said. Read More