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Woodcock highlighted a proposal in the administration’s budget request that would impact the 180-day exclusivity available to first filers of medications. Read More
The agency recommends that companies “consider providing information on whether their drug has any characteristics that would mitigate the risks of overdose, abuse or the development of addiction.” Read More
Australia’s Therapeutic Goods Administration (TGA) has updated its guidance on GMP clearance regulations for overseas manufacturing facilities, clarifying the agency’s processing timelines for various applications. Read More
The FDA is turning to the public for comment on two International Council for Harmonisation draft guidance documents, one designed to help move clinical trials along more quickly, the other designed to make sure that researchers are getting the best possible data before trials can get started. Read More
The FDA’s experiment in whether it can publish the clinical trials data behind drug approvals attracted a lone volunteer and now the agency is seeking public comment on whether they should stick with the project or try something else. Read More
A key Senate committee on Wednesday approved a package of health pricing legislation over the objections of generics makers and pharmacy benefits managers. Read More
The proposed rule would remove safe harbor protection under the Anti-Kickback Statute for manufacturer rebates to pharmacy benefit managers, Part D plans and Medicaid managed care organizations. Read More
Sanofi will hand over its business applications to Google’s cloud platform, which the companies hope will speed up the drugmakers’ operations. Read More