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Sponsors of clinical trials in India must begin reporting all deaths that occur “in clinical trials,” under final guidance issued March 3 by the Central Drugs Standard Control Organization. Read More
Sponsors of clinical trials that rely on data from x-ray and other images should send those images to a centralized reading facility to prevent accidental unblinding or bias that may occur at trial sites, the FDA says. Read More
Drugmakers designing trials for alcoholism treatments can use a primary endpoint of no heavy drinking rather than total abstinence, the FDA says, in an acknowledgement that abstinence as a goal in these studies is often unattainable. Read More
Clinical trial sites using software to obtain patients’ informed consent remotely should make sure the data is stored securely, the FDA says. Read More
The FDA Tuesday outlined new deadlines and procedures for the way drugmakers seek and conduct meetings with the agency before and during reviews of new product submissions. Read More
Spanish regulators are investigating Pfizer sales contracts for possible anticompetitive conduct, following a Supreme Court ruling in November that the drugmaker’s dual-pricing contracts could restrict parallel trade in the EU. Read More
Sponsors of brand, generic and biosimilar drugs applying for marketing authorization through the EU’s centralized procedure must begin including facility inspection information in their applications. Read More
The FDA is warning that Pfizer’s Chantix smoking-cessation aid may cause seizures or, when taken with alcohol, lead to unusual or aggressive behavior. Read More