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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
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
A class action lawsuit claims that Beijing-based Sinovac Biotech misled shareholders and bribed regulators at the China Food and Drug Administration to expedite its drug and clinical trial applications. Read More
The FDA issued a warning letter to a Texas clinical researcher, claiming he deviated from his own investigational plan by enrolling ineligible trial subjects. Read More
The European Medicines Agency revised its guideline on first-in-human clinical trials, highlighting the sponsor’s responsibility for mitigating risks to volunteers.in the study design. Read More
Data integrity, recordkeeping and drug trial oversight violations feature in the UK Medicines and Healthcare products Regulatory Agency’s latest report on good clinical practice inspections. Read More
The European Medicines Agency adopted five product-specific guidances, effective Jan. 1, 2018, outlining requirements for establishing bioequivalence, including clinical study design. Read More
A joint FDA advisory committee voted against recommending approval of Intellipharmaceutics’ extended-release opioid painkiller Rexista, as well as against the claim that it deters abuse. Read More
An FDA advisory committee voted to recommend that Wyeth’s Mylotarg return to the U.S. market as a treatment for CD33-positive acute myeloid leukemia in combination with daunorubicin and cytarabine. Read More
An FDA advisory panel unanimously recommended that the agency approve two biosimilars for the cancer treatments Avastin (bevacizumab) and Herceptin (trastuzumab). Read More