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Most independent, chain and hospital pharmacies are implementing requirements for drug tracing but many are not properly reviewing the data, according to a new report from the HHS Office of Inspector General. Read More
In comments on the FDA’s draft guidance on drug and biologics labeling, Amgen urged the agency to follow a precedent set by a previous agency opinion that a USP monograph title consisting of a core name without a suffix does not apply to biologics whose nonproprietary names include a suffix. Read More
In a retrial, a jury ordered AbbVie to pay more than $3 million to a plaintiff who blamed his heart attack on misrepresentation of the risks posed by AbbVie’s testosterone replacement drug AndroGel. Read More
Senate Health Committee Chairman Lamar Alexander (R-Tenn.) released two draft bills that would provide the FDA with more tools to deal with the opioid crisis. Read More
Sanofi called for removing the requirement for a reference list of SOPs from the requirements for CMC supplements, noting that SOPs are already reviewed as part of GMP inspections. Read More