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Valporate, a treatment for migraine headaches, epilepsy and bipolar disorder, can cause malformations and impede neurological development in babies in the womb. Read More
The European Medicines Agency added new safety information for 15 excipients, including five new ingredients, in its listings of required product labeling. Read More
In a significant policy shift, China plans to accept data from foreign clinical trials in its drug approval process if the drug is already approved overseas. Read More
California Gov. Jerry Brown (D) signed price transparency measures into law that require drugmakers to notify purchasers ahead of large increases and to justify those increases to the state. Read More
Facing a drastic loss of revenue and market share to a competing generic drug, Indivior said it will appeal an adverse federal court ruling on its patent for Suboxone (buprenorphine and naloxone), a sublingual film indicated for the maintenance treatment of opioid dependence. Read More
An FDA policy proposal on expedited generic drug approvals runs counter to the goals of the program and breaks faith with the upcoming GDUFA II agreement with the industry, generic drugmakers said. Read More
As part of a broad effort to increase competition and lower drug prices, the FDA spelled out what it expects from ANDA sponsors seeking earlier meetings to smooth out the review process. Read More