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Under current law, patent holders can transfer patent ownership to Indian tribes, allowing the tribes to claim sovereign immunity and evade review if a dispute arises. Read More
The FDA should revise its draft guidance on ANDA submissions to clarify sponsors’ responsibility for reviewing existing guidances on generics, stakeholders said in comments to the agency. Read More
The EMA’s Pharmacovigilance Risk Assessment Committee recommended contraindicating the use of Zytiga (abiraterone acetate) with Xofigo (radium-223 dichloride) and prednisone/prednisolone, after preliminary clinical trial results showed the combination posed an increased risk of fractures and death. Read More
Although 2017 saw significantly fewer new FDA regulations, other regulatory and enforcement activities at the agency built on existing long-term trends, according to a new report from PriceWaterhouseCoopers (PwC). Read More
The FDA issued two draft guidances aimed at implementing the Drug Supply Chain Security Act’s provisions for an electronic track-and-trace system for certain prescription drugs extending throughout the supply chain — one recommending data and documentation practices and another defining terms such as “suspect products” and “illegitimate products.” Read More
The FDA finalized a Q&A guidance clarifying the International Council for Harmonization’s November 2012 Q11 guidance on development and manufacture of drug substances — giving recommendations for information that should be provided in authorization applications for starting materials. Read More
The city alleged three opioid distributors contributed to the addiction epidemic by over-prescribing opioids and failing to report suspicious orders. Read More
Only three of the nine approved biosimilars in the U.S. have reached the market, with patent litigation often stalling launches even after approval. Read More
The FDA plans to make tools available to provide incentives for doctors or physician groups to collaborate on stem-cell and regenerative medicine products, eventually leading to a biologics license for each doctor or group, CBER Director Peter Marks and Commissioner Scott Gottlieb said in a New England Journal of Medicine article published Thursday. Read More
Investigations and lawsuits against opioid manufacturers and distributors continued as Sen. Claire McCaskill (D-Mo.) accused a drugmaker of blocking a Senate investigation and the city of Chicago sued three distributors. Read More