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Application fees for prescription drug approvals will increase by nearly 20 percent in fiscal 2018, starting Oct. 1, the FDA said in a Federal Register filing. Read More
Intellipharmaceutics artificially inflated its stock prices during the NDA process for its oxycodone product Rexista, a new class-action lawsuit claims. Read More
Managing drug treatments for children may call for communicating with them via Facebook, videos or comics, the European Medicines Agency said in draft guidance on pharmacovigilance practices for pediatric populations. Read More
The European Medicines Agency released a reflection paper to help guide generic drugmakers through the process of setting specifications for in vitro dissolution of immediate-release oral drugs. Read More
The FDA has largely succeeded in expediting the review of drugs with larger health gains, but postmarket trials by companies have fallen behind in confirming some of those benefits, with many not using the gold standard of randomized controlled trials, according to two independent studies. Read More
The FDA’s rules for clinical investigators cover a lot of ground, from how to avoid financial conflicts of interest, to delegating investigator authority to other members of the trial team, to hiring—and sometimes firing—investigators under your charge. The FDA provides all the GCP regulations and guidance documents you need to run a clinical trial, but even those documents can’t answer every question you may have about the people who actually conduct the trial. Read More
The FDA opened the doors to a dramatic new method for treating cancer — the genetic modification of a patient’s immune cells to fight the disease — by granting approval to Novartis’ Kymriah. Read More
An FDA advisory committee voted 12-to-1 against recommending approval of Janssen’s Plivensia (sirukumab) in treating rheumatoid arthritis, saying its safety profile raised too many concerns. Read More
A bill reauthorizing the FDA’s user fee agreements for the next five years and restructuring fees for biosimilars, including the first year of clinical trials, became law Aug.18 when President Trump signed it. Read More
The FDA revised its near-decade-old guidance on developing generic versions of digoxin tablets, calling for more robust testing. The agency reconsidered the guidance in response to a citizen petition from reference holder Concordia Pharmaceuticals. Read More