Frustrated by years of study but no FDA rule requiring effective patient medication information (PMI) for prescription drugs, a Senate committee threatened to use the power of the purse to force some changes to protect patients from drug labeling mistakes.
A new spending framework constructed by congressional budget negotiators would provide some relief from across-the-board sequestration cuts, but it does nothing to protect FDA and Patent and Trademark Office (PTO) user fees from those cuts.
Although the U.S. is several years behind Europe in how it treats allergies, it may be about to catch up. The FDA’s Allergenic Products Advisory Committee (APAC) is slated this week to look at the first sublingual allergy tablets to come down the pike in the U.S.
Despite being haunted by the progressive multifocal leukoencephalopathy (PML) specter raised by natalizumab, Takeda Pharmaceutical Co. Ltd.’s Entyvio got strong support Monday from two advisory committees that weren’t overly concerned by trials that missed some endpoints.
Closing the book on another quirky chapter in the life of Dendreon Corp.’s Provenge, two hedge fund analysts have each agreed to a six-month suspension and $25,000 civil penalty in a settlement with the SEC over statements made in 2010 regarding the cancer vaccine that the commission considered “materially misleading.”
Since China, Canada and Mexico are the U.S.’ biggest trade partners, it should come as no surprise that they have the most import alerts involving U.S. FDA-regulated products.
Drugmakers shouldn’t be forced into the waste disposal business. That’s the gist of a federal lawsuit filed by several industry trade associations in the hopes of throwing out a King County, Wash., regulation requiring drugmakers to set up and maintain secure take-back programs for unused prescription and over-the-counter drugs – at no cost to King County residents.
While patents continue to clog the U.S. biosimilar pipeline, other countries are benefiting from an increasing flow of the discounted copies of complex biologics.
