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A libertarian advocacy group that backs right-to-try laws pressed the FDA in federal court to release information about the agency’s “incredibly expeditious” decision to authorize the treatment of two Ebola patients with an unapproved drug. Read More
The European Medicines Agency added answers to 60 new questions in its list of inquiries from stakeholders regarding the November launch of its new EudraVigilance drug safety reporting program. Read More
FDA Commissioner Scott Gottlieb will deliver a keynote address Nov. 8 at a public FTC workshop in Washington on competition in prescription drug markets. Read More
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