We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The President’s Cancer Panel highlighted the sharp increase in U.S. cancer drug prices in a 70-page report to President Trump, calling for more value-based pricing, more competition in the drug market and “meaningful communication” about treatment options. 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
The FDA announced plans for additional research into the impact of drug promotion on consumers’ understanding of prescription drug risks and benefits, and said a more targeted presentation of risks may help consumers retain key information. Read More
Last month, Commissioner Scott Gottlieb said the decline in approvals was temporary, attributing the slowdown to drugmakers’ implementation of the agency’s new impurity guidelines. 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
Generic manufacturer Impax Laboratories agreed to pay $35 million to settle pay-for-delay lawsuits brought by a class of direct purchasers of the acne medication Solodyn (minocycline), sold by Medicis Pharmaceutical, a unit of Valeant. Read More
The FDA’s approvals of generic drugs picked up slightly in February after January’s steep dropoff, while overall ANDA submissions dropped sharply, according to the agency’s latest monthly report. Read More
A Louisiana federal judge managing the tide of lawsuits against the blood thinner Xarelto (rivaroxaban) ordered them to be prepared for trial in individual federal courts nationwide, with selection and discovery to take place in two waves of 600 cases each. Read More