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The FDA wants biosimilars makers to retain for at least five years reserve samples of products used in comparative pharmacodynamic and pharmacokinetic studies intended to support an ANDA. Read More
Generics makers are asking the European Commission to clarify new requirements for factory acceptance and site acceptance testing, including the number of batches that need to be validated when bracketing is applied. Read More
The FDA is hoping that a study of spousal communication related to direct-to-consumer prescription drug advertising will help it make better recommendations for these ads. Read More
The FDA plans to issue a proposed rule this year streamlining requirements for fixed-dose combination prescription and over-the-counter drugs into one set of regulations, according to an updated list of priorities released Friday. Read More
California-based Amgen may soon be the first to get a new class of cholesterol-lowering biologics onto the European market, following a positive opinion from the European Medicines Agency on Friday. Read More
To ensure data integrity, drugmakers should implement data controls in their manufacturing processes aligned with the risk to product quality, the Medicines and Healthcare products Regulatory Agency says. Read More
The FDA should issue guidance officially adopting U.S. Pharmacopeia standards in its visual particle inspections of injectable drugs, law firm Hogan Lovells says in an April 13 citizen petition submitted to the agency on behalf of an unnamed drugmaker. Read More
The majority of fixed-dose combination analgesics and antipsychotics on the Indian market have never been approved, leading to the sale of millions of doses of unsafe drugs, a new study concludes. Read More
Toronto, Canada-based Intellipharmaceutics expects to file an NDA for its opioid painkiller Rexista XR within the next year, after receiving notification from the FDA that it won’t need to conduct Phase III clinical trials. Read More