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The doctor lost his medical license and position as a professor at Brown University’s medical school, and was ordered to pay over $750,000 dollars to insurance companies. Read More
Potential or actual impurities in drugs should be studied for their mutagenic properties, according to a revision to an ICH guideline addendum on mutagenic carcinogens, now adopted by the FDA. Read More
Judicial precedent holds that companies or entities are only liable under the FCA if they were reimbursed specifically as a result of false representations, he said. Read More
As part of its multi-pronged campaign against the opioid epidemic, the Justice Department will continue its crackdown on opioid overprescribing through False Claims Act enforcement, according to a senior DOJ official. Read More
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The FDA should revise its draft guidance on ANDA submissions to clarify sponsors’ responsibility for reviewing existing guidances on generics, stakeholders said in comments to the agency.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