Simplifying Global Compliance
The FDA on Tuesday gave four drugmakers the green light to market generic versions of Otsuka’s blockbuster Tourette syndrome therapy Abilify, saying a labeling carveout would protect the brand maker’s pediatric exclusivity on the drug. Read More
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The requirement, spelled out in draft guidance Tuesday, would apply to drugs with estrogenic, androgenic or thyroid activity.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 FDA saw the number of bioresearch monitoring inspections increase 11 percent in fiscal year 2014, to 1,136 from 1,019 in 2013. Read More
The EMA wants industry suggestions on the best ways to get these drugs approved without having to prove bioequivalence. Read More
Once the guidance is finalized, companies will have two years to stop submitting hard copies of their materials. 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
The FDA claims the drugmaker can’t prove sufficient harm to warrant continued exclusivity protection. 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
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