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Sponsors of BLAs, NDAs, and ANDAs should justify the amount of excess medication for injectable drug products they plan to pack in vials and ampules, according to an FDA draft guidance. Read More
While the FDA sees great potential for Bayesian statistics in Phase II clinical trials, the agency is not yet ready to endorse the method for Phase III studies. Read More
In a bid to cut down on orphan drug developers wasting agency time, the FDA is outlining new, detailed guidelines for what constitutes a legitimate topic for formal and informal presubmission meetings. Read More
The World Health Organization lashed out at Johnson & Johnson and Gilead for selling oral hepatitis C drugs that are too expensive to be adopted in developing countries. Read More
The European Medicines Agency is planning a series of May meetings with industry to unveil the process it plans to use to determine whether clinical trial data is considered confidential under its new transparency rules or whether it must be disclosed. Read More
Unlike in the EU, Swiss regulators will not accept marketing authorization applications for biosimilars of low-molecular-weight heparin products already approved in Switzerland. Read More
The FDA has banned Canadian generics maker Apotex from importing drugs to the U.S. made at its Bangalore, India, site, pending quality upgrades. Read More
The EU’s primary biotech lobbying group is pushing back against same-name biosimilars, arguing that physicians would find such a system confusing. Read More
The FDA said Thursday that all manufacturers have voluntarily complied with an agency ban on selling acetaminophen/opioid combination drugs that use more than 325 mg of acetaminophen per tablet. Read More
The FDA has closed out a warning letter issued to West-Ward Pharmaceuticals after the generic drugmaker completed a two-year overhaul of parts of its quality system. Read More