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Generic and brand drugmakers continue to push for an expedited agency review process with clearly defined timelines for updating drug labels based on safety information, according to comments on the FDA’s proposed drug labeling rule. Read More
Drugmakers seeking approval of products with hormonal effects should submit an assessment with their applications that evaluates whether they would be harmful if released into the environment.
The requirement, spelled out in draft guidance Tuesday, would apply to drugs with estrogenic, androgenic or thyroid activity. Read More
The latest clinical trial results for Amgen’s talimogene laherparepvec immunotherapy may not be as strong as the company hoped, say FDA advisory committee briefing documents. Read More
Drugmakers in Europe must record and report suspected adverse events that are brought to their attention concerning drugs they donate outside the EU to treat neglected tropical diseases. Read More
Drugmakers in Europe will need to submit proposed educational materials in a specific format and with specified content as part of their risk-mitigation strategy, under a draft addendum to the European Medicines Agency’s good pharmacovigilance practices guidelines. Read More
HHS has promised to protect the maker of the experimental Ebola virus drug ZMapp from legal liability, meaning the company can’t be sued for claims of injury or loss related to use of the monoclonal antibody cocktail. Read More
The HHS Office of Inspector is urging Congress to rewrite the Medicare Part D in the Social Security Act to allow for collection of additional rebates from drug companies. Read More
European regulators are warning that combining certain hepatitis C drugs with the antiarrhythmic drug amiodarone could cause slow heart rate or heart block. Read More